Top industry experts weigh in on what the new year holds for the pharma industry.

PREDICTION #1: In 2023, the chasm will widen between those companies investing in analytics-based, digital-first commercial models and those still sitting on the fence and taking a measured approach

 

Alan Kalton

Life sciences companies are notoriously cautious. However, COVID-19 put many companies in the uncomfortable position of forcing new ways of working, engaging with customers, and new technologies. For many companies, the changes are sticking, ushering in the digital-first era.

We have started seeing the impact of the adoption of new technologies, such as platform intelligence solutions, ‘on the ground.’ In fact, 89% of companies surveyed by DHC Group reported that they are successfully executing an AI-driven omnichannel strategy across sales and marketing and scaling up.1

Gone are the days when digital and analytics technologies were merely a shiny new toy to test-run in isolated markets. Today, many companies understand the impact of AI and recognize that it needs to be powering engagement across all markets. As the global director of field force AI enablement at Novartis noted recently during our Omnichannel AI Masterclass, “in three to five years, I hope that our industry has moved to where AI isn’t a buzzword, but rather, it’s baked into the mainstream of our go-to-market strategies because it’s so essential.”

The organizations delaying investment in scaling intelligence platforms across the organization will see a widening gap between them and their competitors in terms of influence, customer engagement and ultimately, financial success.

Alan Kalton, Global SVP

Aktana

PREDICTION #2: Companies will connect data science models to day-to-day operational activities to execute on strategic business goals across the entire organization

 

David Ehrlich

Next year, we will see the start of the next chapter in AI for life sciences commercial organizations.

Traditionally, AI has lived in one of two places–either with headquarters teams, analyzing massive amounts of data to generate ‘smart’ conclusions, or within discrete applications, helping to tune the application’s impact (i.e. marketing automation systems). At headquarters, AI is used to strategically assess business opportunities on a broad scope whereas the tactical AI embedded into individual applications is very specific and application limited.

Both are valuable, but what’s missing is the connective tissue between HQ’s broad-scope AI to the various operational systems required to execute HQ’s strategic business goals. Such connective capability would reach into the multiple operational systems required for execution and guide the appropriate actions. As a result, operating teams could agilely deploy data science models to guide a wide range of day-to-day activities.

Ultimately, companies will be both more effective (more good decisions) and more efficient (less bad decisions that waste resources), cycling through the “try it, fix it” rhythm much faster to continuously improve AI’s outputs across the entire organization.

David Ehrlich, CEO & Chairman

Aktana

PREDICTION #3: AI-driven identification of digital opinion leaders (DOLs) will accelerate evidence dissemination

 

Deepak Patil

Medical Affairs teams are racing to provide a personalized “Netflix-like” engagement for ever-expanding targets, predicting needs and preferences and then delivering unbiased scientific information in the most useful formats and channels. Field medical affairs or medical science liaisons (MSLs), work to engage with physician key opinion leaders (KOLs), but also have a new target: digital opinion leaders.

DOLs, in essence, are KOLs active on digital platforms. DOLs may be practicing or non-practicing HCPs but have major influence over consumer behavior and informing other physicians. Some rise to near-celebrity status, such as Dr. Mikhail Varshavski–better known as Dr. Mike–who has a combined social media following of over 21 million people. He has been featured in Time, Men’s Health, Business Insider, and People Magazine, to name a few. Also, Dr. Don Dizon is a professor at Brown University and director of medical oncology at Rhode Island Hospital who shares cancer research via video primarily on TikTok. He has 38,000 followers.

In addition to doctors, nearly 90% of all adults in the U.S. search for health information on Facebook, Twitter, YouTube, and other social media sites. From doctors to patients, MSLs can multiply their influence by engaging with the right DOLs. AI and natural language processing technologies can help by mining available information–based on specialty, therapeutic area expertise, followers, outreach network, and posts–to help identify the right influencers to engage and cultivate a relationship.

Next year, as the role of the MSL continues to expand and evolve, MSLs will demand new smart technologies to help them engage with the growing fleet of digital influencers. And when these relationships are formed, MSLs will increase education and information dissemination faster and farther than they have ever done before.

Deepak Patil, Senior Director of Medical Strategy

Aktana

 

PREDICTION #4: Decentralized clinical trial market will continue to grow, even in economic downturn

 

Joel Morse

Industry leaders are debating whether or not decentralized clinical trials (DCTs) will become the norm rather than the exception across therapeutic areas–but, it’s neither. In 2023, the question will no longer be an “either/or” scenario. There will always be some trials and some elements of a trial that should not be decentralized. In 2023, however, the first question all sponsors will consider at the start of protocol design will be “what aspects of the trial can be decentralized.”

For some trials, the answer may be “all of them,” and for other trials, such as highly complex oncology trials, the answer may be “very few of them” as each trial has unique needs. However, with the rapid maturation of digital technologies and increasing comfort level with digital tools by patients and doctors, sponsors will adopt a digital-first mindset for every trial.

Digital technologies will be considered from the start rather than force-fitting them into a trial mid-way, which will ensure a more successful trial design overall. The financial and time savings of the DCT model, coupled with the remarkable patient benefits of greater access, increased convenience, and optionality, are too compelling for sponsors not to lead with it for each trial they invest in.

Joel Morse, Co-Founder & CEO

Curavit Clinical Research

PREDICTION #5: Digital therapeutics companies will focus on the difficult last mile to commercialization

 

Dave Hanaman

Historically, digital therapeutics (DTx) companies have directed about 95% of their effort into gaining FDA approval and 5% into market access strategy. In 2023, this will shift to a 60%/40% split, with DTX companies having an earlier focus on the commercialization process, while simultaneously working toward earning FDA approval.

This ‘last mile’ is completely unchartered territory for DTx companies.They face new obstacles bringing their therapeutics to market. For example, physicians’ lack of awareness of the DTx and their inability to easily prescribe them. There are still many unknowns around getting DTx products on the formulary and how to prescribe them to patients–doctors can’t just write a prescription and send patients off to the local drugstore when prescribing the use of an app.

And, whereas traditional drug companies may spend up to $300 million to launch a product, most DTx startups don’t have the budget to spend on commercialization strategies such as building a field team, equipping marketing teams with supporting analytics technology, and initiating patient support programs to help patients learn to use these software-based therapeutics.

Dave Hanaman, Co-Founder & Chief Commercial Officer

Curavit Clinical Research

PREDICTION #6: Clinical trial sponsors will drive a new framework for DCT technology and services (rather than the other way around)

Even with nearly nine in 10 sponsors saying they will use some elements of DCT technologies in their trials, we still have a lot to learn. We’ll continue to see a lot of experimentation in trying to understand the most effective new methods, technologies, and processes for designing and executing DCTs and improving various aspects of clinical research. But, with business models in flux and an uncertain economy, we’ll see more disruption in the DCT software space, as technology providers pivot to meet industry needs.

For instance, technology providers will work to resolve the complexities of DCT software integration, and drill down to solve specific trial problems rather than offer ‘end all be all’ solutions to sponsors that prefer a hybrid approach. Until recently, the progress of DCTs has been largely driven by providers – often, working in a bubble without collaborating closely with trial sponsors.

In 2023, sponsors will take the lead. Rather than technology providers dictating what their product/services can do to improve clinical research, sponsors will seek technology providers that solve their specific challenges. As they become more researched and familiar with DCT technologies, sponsors will define what trial improvements are required, and successful technology manufacturers will pivot accordingly.

Joel Morse, Co-Founder & CEO

Curavit Clinical Research

PREDICTION #7: Next year, decentralized and hybrid clinical trials will become simply “clinical trials”

 

Sanskriti Thakur

The decentralized clinical trial (DCT) model works and works well. It’s no longer a leap of faith, as a 2022 study from the Tufts Center for the Study of Drug Development shows that DCTs can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million and $39 million ROI, respectively. COVID-19 made DCTs a necessity. Positive returns will make DCTs the de-facto standard.

Expect 2023 to be a pivotal year, capping a year or more of strong growth² in decentralized and hybrid clinical trial deployment. The next evolution of DCTs will involve self-service tools that enable sponsors and sites to deploy and operate global studies on a common platform using standardized processes. We see evidence of this pivot from customers and partners who aim to leverage digital tools across their pipeline. The industry is no longer dipping their toes in the DCT water; rather, leading pharmaceutical companies like GSK and AstraZeneca, are expanding its use.^{2, 3}

We are living the evolution of clinical trials – similar to how consumers migrated to online banking without even realizing that a major shift was taking place in their everyday lives. Sponsors, sites, and patients will expect digital tools to drive clinical trial performance, superior experience, greater diversity, and better outcomes.

Sanskriti Thakur, Chief Growth Officer

Medable

Sources:

1. The DHC Group, “The State of Omnichannel HCP Engagement in Pharma,” (November 2022).
2. 2022 forecast: decentralised trials to reach new heights with 28% jump, https://www.clinicaltrialsarena.com/analysis/2022-forecast-decentralised-trials-to-reach-new-heights-with-28-jump/
3. https://www.astrazeneca.com/r-d/digital-health-revolutionising-healthcare-for-patients.html
4. https://www.businesswire.com/news/home/20220907005594/en/Medable-Selected-by-GSK-to-Power-Decentralized-and-Hybrid-Clinical-Trials-Across-Global-Product-Portfolio

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. Decentralised oncology trials, for example, have shown actual predictive outcome value. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.1 And, digital therapeutics have emerged as an effective treatment for chronic diseases, including mental illness. The rapid innovation is both exciting and disruptive, so it’s important to strategise accurately for what we can expect in the year ahead.

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs.

Traditional protocol designs are built upon years of empirical evidence and consensus among highly rated peer reviewed journals. For new decentralised approaches, this is practically non-existent. This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

Curavit is currently conducting a decentralised trial for a digital therapeutic that began with discussions with the FDA. In this case, the indication was well-known, treated for decades by traditional medical interventions, and copious peer reviewed data to call upon. However, since the route of administration itself was new – i.e., digital rather than in pill form – all stakeholders recognised how crucial it would be to involve the FDA early and often. Specifically, they discussed which patient survey format would be best, which scores to include or exclude, and acceptable means of data capture.

As this collective body of experience continues to proliferate, 2023 will see additional FDA guidance. It is likely that the FDA will address various elements associated with DCTs more granularly than ever. These may include best practices for measuring digital endpoints, biomarkers, and telemedicine and ePRO (Patient Reported Outcomes), as well as risk factors most concerning to the FDA. For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting, the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance.2

Prediction 2: More clinical trial services will become remote, beyond just patient monitoring.

We will see continued increases in remote clinical trial activities and services in 2023, such as remote monitoring, remote site staff training, remote site activation visits, remote quality management meetings, remote safety management meeting,s and more.

These unprecedented clinical trial activities represent a fundamental shift that is still unfolding. There was a time when Source Data Verification (SDV) by any other means than frequent and extremely costly on-site CRA visits was unthinkable. We now see continuing proof points that conducting SDV remotely can not only save time and travel costs, but can also increase quality.

Curavit recently worked on a 28-site, US-based trial where more than half of the source data verification was conducted remotely with secure, remote access to the eTMF and EDC systems. Instead of using generalised, on-site CRAs, Curavit’s therapeutic area specialists handled this significant task from afar, prioritising specific expertise over physical proximity. This had a significant impact on data quality and speed, as well as reductions in travel and costs. Curavit was also able to conduct additional Q/C measures simultaneously, which otherwise would have been a separate process.

Prediction 3: AI innovation will expand its application to enhance patient experience.

Although “Enquire Here” buttons are common for large patient enrolment providers, recent advances in Natural Language Processing (NLP) – a form of artificial intelligence or AI – allow for far greater, more meaningful, and effective patient engagement. Technologies such as BERT3 and GPT-3 catapult NLP capabilities beyond basic processing, into the realm of language intelligence. Potential applications will surpass current-day screening chat bots, which automate FAQ workflow and are only capable of answering the most basic patient questions.

In 2023, expect to see AI innovations improve enrolment agility and, most importantly, the patient experience in a clinical trial. For instance, NLP will respond to patient concerns or enquiries with more humanised responses and alert clinicians faster and automatically. This will, in turn, improve patient interest, trust, engagement, enrolment, and clinical trial retention. In addition to patient benefits, AI will enable actionable real-time metrics and analysis and a near-immediate feedback loop on the investigational drug’s impact on patients’ daily lives.

Prediction 4: digital therapeutics companies will focus on the difficult last mile to commercialisation.

Historically, digital therapeutics (DTx) companies have directed about 95% of their effort into gaining FDA approval and 5% into market access strategy. In 2023, this will shift to a 60%/40% split, with DTx companies having an earlier focus on the commercialisation process, while simultaneously working toward earning FDA approval.

This ’last mile’ is completely unchartered territory for DTx companies. They face new obstacles bringing their therapeutics to market – for example, physicians’ lack of awareness of the DTx and their inability to easily prescribe them. There are still many unknowns around getting DTx products on the formulary and how to prescribe them to patients – doctors can’t just write a prescription and send patients off to the local drugstore when prescribing the use of an app.

And, whereas traditional drug companies may spend up to $300 million to launch a product, most DTx startups don’t have the budget to spend on commercialisation strategies such as building a field team, equipping marketing teams with supporting analytics technology, and initiating patient support programs to help patients learn to use these software-based therapeutics.

Beyond 2023 – the Sovereign Patient ID

The concept of patients owning their own data has been around since the advent of electronic health records. However, 2023 will see new technologies such as blockchain and smart contracts bring the Sovereign Patient ID concept closer to reality. This will give the patient the ability to own their own identity and associated data on their own devices, as opposed to their identity being created and stored separately by each service provider: a state of error prone, redundant inefficiency. The life sciences industry will collaborate and share lessons learned with other verticals that are currently exploring the same concept, such as “Self-Sovereign Identity” (SSI).4

This problem will not be solved in 2023, but progress will be made.

References
1. Gresham G, Hendifar AE, Spiegel B, Neeman E, Tuli R, Rimel BJ, Figlin RA, Meinert CL, Piantadosi S, Shinde AM. Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med. 2018 Jul 5;1:27. doi: 10.1038/s41746-018-0032-6. PMID: 31304309; PMCID: PMC6550281.
2. Chapman, J. An FDA Perspective on Decentralized Clinical Trials: Part 1. July 28, 2022.
3. Devlin, J, Chang, M.W. Open Sourcing BERT: State of the Art Pre-Training for Natural Language Processing. November 2, 2018.
4. Preukschat, A., Reed, D. Self-Sovereign Identity- Decentralized Digital Identity and Verifiable Credentials. Manning. 2021.

About the Author

Dr. Pam Diamond is co-founder and chief medical officer of Curavit, a virtual contract research organisation (VCRO) that designs and executes decentralised clinical trials. She is a board-certified, Boston-based otolaryngologist/head and neck surgeon who was affiliated with Harvard Medical School (HMS) and Massachusetts Eye and Ear Infirmary (MEEI) for over 30 years. At Curavit, Dr. Diamond provides medical and scientific expertise and oversight to the design and execution of Curavit’s decentralised clinical trials. She received her medical degree from the University of Rochester School of Medicine and completed her otolaryngology/head and neck surgery residency at Harvard Medical School/MEEI.

Estimates of the US digital therapeutics (DTx) market have jumped by billions each year since 2019 and, as of November 2022, is expected to hit $11.2 billion by 2030, while the global DTx market is projected to reach $56 billion over the next five years. The market was driven by the FDA fast-tracking pandemic-related approvals for prescription DTx products to help treat the sharp increase in patients with anxiety and depression.

There are many types of DTx manufacturers, ranging from emerging DTx companies to public companies like Pear Therapeutics and Akili Interactive to global pharmaceutical companies like Roche and AstraZeneca, which are acquiring or partnering with DTx startups to enter the market.

To add further complexity, there are FDA-approved prescription digital therapeutics, nonprescription digital therapeutics, and those that may eventually seek approval.

Traditional clinical trials are complex, but architecting a DCT from the ground up is even more complicated. And while nearly nine in 10 sponsors say they use some elements of DCT technologies in their trials, fully virtual trials are still rare. At a recent conference, one top-10 pharma executive said that while more than half of their trial site visits are virtual, no trials are 100 percent virtual.

One reason for this is because designing a DCT protocol requires highly specialized expertise. Sponsors are leaning into the decentralized approach to speed patient recruitment, increase access and diversity, improve efficiency, and capture real-world data, but are still developing protocol designs within a traditional framework. Expert DCT protocol designers, however, review trial designs to determine what aspects can be decentralized (and which cannot) and the best way to decentralize those elements. They factor DCT considerations into the process from the beginning, instead of shoehorning digital elements into the trial later or superimposing them over traditional designs.

Swing Therapeutics is a DTx company that was founded less than three years ago with $9 million in seed funding and that wrapped up $10.3 million in Series A funding in June. The company is running a hybrid trial of its investigational DTx for fibromyalgia and is expected to enroll up to 300 participants recruited from 15–25 physical sites, plus a virtual site.

The virtual site provider is remotely recruiting, screening, consenting, and enrolling participants in Swing’s PROSPER-FM trial from across the US.

By eliminating physical and geographic barriers to trial participation and execution, they have improved patient enrollment by 10x. In fact, the virtual site has surpassed all the bricks-and-mortar sites in patient enrollment.

Many virtual or decentralized clinical trial (DCT) specialists are successful in supporting DTx companies, as DCTs are well-suited to support prescription and non-prescription DTx studies. Fundamentally, there are no physical logistics with a DTx—no shipping, storing, chain of control, cold storage, or biohazards, and endpoints can often be captured within the DTx application itself, naturally aligning DCTs with DTx studies. Ultimately, Swing hopes for FDA-approval and will go to market.

“We are focused on getting patient recruitment right,” says Mike Rosenbluth, PhD, chief executive officer at Swing. “A virtual services model enables us to efficiently recruit participants representative of the entire patient population. It solves a huge challenge and will be critical to rapidly develop the evidence needed to bring an effective digital therapy to millions suffering from chronic illness.”

And, while the research and development processes involved in digital therapeutics are innovative, commercializing a DTx may require more out-of-the-box thinking. Many presenters at the fall DTx East event said that even after successfully earning FDA-approval, their therapeutics are failing in the marketplace. There are new challenges to address such as lack of awareness by clinicians and their inability to easily prescribe DTx to patients.

This last challenge is uncharted territory for DTx companies. And whereas traditional drug companies average between $200–$300 million to launch a product, most DTx companies don’t have that kind of funding available to them. Plus, there are various launch challenges, patient support programs to implement, and sales and marketing teams to recruit and train.

For Swing Therapeutics and other DTx companies to be profitable or even sustainable, they need to make it easy for clinicians to prescribe digital therapeutics and get reimbursed, while also making it easy for patients to use DTx.

A new CMS code that went into effect in April 2022 will help by making it easier for commercial and Medicaid plans to cover these therapies. Yet, there are still many questions about what payment models will work best and how to get on formularies and more.

Virtual CRO Curavit Clinical Research has tapped investors for cash, securing $5 million in series A funds to support its targeting of the digital therapeutics space.

Investors and buyers say pharma-related technologies are piquing their interest even within a tumultuous economy.

While the digital health ecosystem is anticipating a massive reset in 2023, pharmaceutical companies are willing to invest in clinical trial technology and digital therapeutics. Also, retail companies like CVS and Walgreens and payers are interested in pharma-related innovations. All this presents a potentially big opportunity for digital health investors and companies alike, experts say.

“One segment that is still eager to spend is pharma, particularly on the clinical trials sector” said Dr. Sunny Kumar, a partner at the venture capital firm GSR Ventures. According to the Digital Health Business & Technology database, companies focused on digital health trial technology have raised nearly $165 million this year across nine deals, including a $5 million investment into virtual research organization Curavit last Tuesday.

GSR’s portfolio companies include Medable, one of the industry’s biggest decentralized trial technology companies that received $304 million in funding last October. Kumar said companies like this have a tightly aligned incentive structure. “No one is truly recession proof, but companies in that space are still getting [interest] because they’re bringing a certain value proposition to the table. They’re decreasing clinical trial time and bringing drugs to market faster,” he said.”

Dr. Justin Norden, also a partner at GSR Ventures, said he prefers companies that sell to the pharma sector.

“Pharma makes decisions faster for bigger contracts with research and development focused on a return of investment,” Norden said. “If you’re a digital health company that’s going to monetize with pharma, it’s going to be a faster and easier path.”

Scott Barclay, managing director at venture capital firm Insight Partners, has invested in Trialjectory, an AI based trial matching platform that uses self-reported clinical information to facilitate clinical trial search, matching and enrollment. The company raised $20 million in a Series A round in February.

“We need to bring software and appropriate data liquidity to trials,” Barclay said. “Trials need to be better, faster, more expansive and more inclusive.”

Digital therapeutics is another area of potential investment for pharma companies, particularly as payers are increasingly willing to cover them. At the HLTH conference held last week in Las Vegas, Teva Pharmaceuticals said it was partnering with HealthTap, a virtual care management company, to expand its digital health platform. Manny Montalvo, head of digital health and innovation at Teva, said technology partnership is vital to its overall strategy on digital.

“We’re always looking to collaborate whether it’s plugging into an [electronic medical record] system, directly ordering online or something else,” Montalvo said. “If someone has better software than we do, we’re always looking to build off the platform that we have.”

Disruption in pharma is also coming from the retail side, experts say. Both CVS Health and Walgreens are investing in different technologies to create more efficient operations, including entering the de-centralized clinical trial space. Rina Shah, Walgreens’ vice president of the pharmacy of the future, said the company is also using technology to improve fulfillment, prescription renewals and medication adherence.

“Technology and analytics really drive the core infrastructure of how we deliver care all the way,” Shah said. “Our micro fulfillment center is primarily driven by technology and automation. We’re able to fulfill hundreds of thousands of prescriptions with the oversight of a pharmacist and technician onsite.”

It also has invested heavily in technology in terms of how it engages with patients. Shah said it works with both payers and providers to use “behind the scenes data” that helps the retail company better understand the patients needs.

In the area of improved pharma operations, Paul Markovich, CEO of Blue Shield of California, said the health insurance company aims to use technology to improve the pharmacy value chain. The pharma value chain is the process in which medications go to market. Companies like Blue Shield of California play an integral role as the ones who reimburse for these medications.

“We’ve laid out a vision for what a more efficient, consumer-centered pharma value chain will look like, but you’ve got to do it at scale,” Markovich said. “We’ve gone through a request for proposal but we’re still in the middle of trying to figure out which vendors could fit with our vision.”

This week’s Lab Notes has reports on a cancer research collaboration, a biotech startup’s multimillion-dollar seed funding round, a local firm’s investment in a virtual contract research organization and more

Industry’s first virtual CRO that specializes in decentralized clinical trials achieves key milestones

PHILADELPHIA and NEW YORK, Nov. 14, 2022 /PRNewswire/ —  Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs), today announced it raised $5 million in Series A funding to accelerate its growing portfolio of research in the global digital therapeutics (DTx) market (projected to grow at a CAGR of 31.4% through 2026). The new funding will be used to expand the company’s DCT capabilities, partnerships, and market adoption of Curavit’s virtual CRO services and platform for prescription and non-prescription digital therapeutics trials.

The funding was led by early-stage technology investor Osage Venture Partners with additional investment from Royal Street Ventures and Narrow Gauge Ventures. It adds to early investments from Curavit founders and individual investors, including industry veterans Clark Golestani, former president of emerging businesses and global CIO of Merck, and former president and co-founder of Veeva Systems, Matt Wallach.

“In order to dramatically lower the cost and increase the speed of clinical trials, the industry must take a new, digital-first approach,” said Wallach who serves on Curavit’s board of advisors. “Curavit was founded by seasoned veterans with deep experience in that sweet spot where technology innovation meets process excellence so I’m proud to play a part in their journey to improve clinical trials.”

“This is an important milestone for Curavit and the industry’s continued momentum in digital therapeutics and decentralized approaches to clinical research,” said Joel Morse, co-founder and CEO of Curavit. “Traditional trial processes and timelines are insufficient – and they limit patient participation. New digital therapeutics are ideally suited for a DCT approach and will help improve access and drive new unique therapies to patients faster.”

The funding brings Curavit’s total capital raised to more than $8 million. Curavit has more than doubled its revenue in 2020 and 2021 and is on the same pace this year. More than half of its customer base are emerging digital therapeutics companies whose clinical research needs align with Curavit’s focus on virtual site services and DCT expertise.

“We are pleased to partner with Curavit on the next phase of their journey,” said Nate Lentz, Managing Partner at Osage Venture Partners. “The COVID-19 pandemic and rapid growth of digital therapeutics has driven a new digital model, where clinical trials are increasingly decentralized and require a new combination of technologies, services, and expertise not available in the marketplace. Curavit’s team and offering are well-positioned to fill this void and become the leading virtual CRO.”

Since its founding in late 2019, Curavit has accomplished key successes on its mission to bring clinical trials of innovative therapies to more patients in the cloud, including:

• Support for important research with digital therapeutics companies, including Swing Therapeutics, Lark Health, Curio, and Sana.
• Strategic partnerships with life sciences digital technology and data providers, including Ripple Science, for its direct-to-patient software platform; ixlayer, to provide easy access to clinical-grade diagnostic lab testing in DCTs; and 1nHealth, for digital patient recruitment and enrollment.
• Hired experienced industry leaders in top positions including Jay Collier as COO, Candice Del Rio as director of clinical operations, and Chris O’Shaughnessy as VP of business development.

In other news, Curavit joined the Digital Therapeutics Alliance, whose aim is to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics with patients, clinicians, payors, policymakers through education, advocacy, and cross-industry collaboration.

Osage Venture Partners (OVP) is a venture capital firm located just outside of Philadelphia, PA. It partners with exceptional entrepreneurs, building the next generation of leading B2B software and tech-enabled services companies. OVP has consistently focused on this strategy since its inception in 2005, making over sixty investments in early-stage B2B companies over that time. For more information, visit OsageVenturePartners.com.

Curavit Clinical Research is a full-service, virtual contract research organization (VCRO), focused on designing and executing digital-first decentralized clinical trials (DCTs). Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, ultimately bringing trials to patients in the cloud. Curavit’s digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies more effective across representative populations. Visit www.curavitclinicalresearch.com.

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SOURCE Curavit Clinical Research

Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs), today announced it raised $5 million in Series A funding to accelerate its growing portfolio of research in the global digital therapeutics (DTx) market (projected to grow at a CAGR of 31.4% through 2026). The new funding will be used to expand the company’s DCT capabilities, partnerships, and market adoption of Curavit’s virtual CRO services and platform for prescription and non-prescription digital therapeutics trials.

What You Should Know:

– Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) announced it raised $5M in Series A funding to accelerate its growing portfolio of research in the global digital therapeutics (DTx) market. The round was led by  Osage Venture Partners with additional investment from Royal Street Ventures and Narrow Gauge Ventures.

– The new funding will be used to expand the company’s DCT capabilities, partnerships, and market adoption of Curavit’s virtual CRO services and platform for prescription and non-prescription digital therapeutics trials.

In addition, Curavit joined the Digital Therapeutics Alliance, whose aim is to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics with patients, clinicians, payors, policymakers through education, advocacy, and cross-industry collaboration.

Curavit Background

Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, ultimately bringing trials to patients in the cloud. Curavit’s digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies more effective across representative populations

The funding round was led by Osage Venture Partners with additional investments by Royal Street Ventures and Narrow Gauge Ventures, the company said in a Nov. 14 press release. To date, the company has raised more than $8 million.

The money is expected to support Curavit’s expansion of decentralized clinical trial offerings, partnerships and adoption of its CRO services and platform for prescription and non-prescription digital therapeutics trials. The company cited estimates the global digital therapeutics market will experience growth of 31.4% by the end of 2026.

“Traditional trial processes and timelines are insufficient and they limit patient participation,” Joel Morse, co-founder and chief executive of Curavit, said in the press release. “New digital therapeutics are ideally suited for a DCT approach and will help improve access and drive new unique therapies to patients faster.”

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Curavit launched in late 2019, just months before the onset of the COVID-19 pandemic. Disruptions caused by the crisis initiated a global embrace of decentralized clinical trials that have become more the norm than exception.

The company also said more than half of its customer base are companies focused on emerging digital therapeutics that pair with virtual site services and decentralized clinical trial experience.

Industry’s first virtual CRO that specializes in decentralized clinical trials achieves key milestones

PHILADELPHIA and NEW YORK, Nov. 14, 2022 /PRNewswire/ —  Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs), today announced it raised $5 million in Series A funding to accelerate its growing portfolio of research in the global digital therapeutics (DTx) market (projected to grow at a CAGR of 31.4% through 2026). The new funding will be used to expand the company’s DCT capabilities, partnerships, and market adoption of Curavit’s virtual CRO services and platform for prescription and non-prescription digital therapeutics trials.

Curavit, the industry’s first virtual CRO that specializes in decentralized clinical trials reaches key milestones.

The funding was led by early-stage technology investor Osage Venture Partners with additional investment from Royal Street Ventures and Narrow Gauge Ventures. It adds to early investments from Curavit founders and individual investors, including industry veterans Clark Golestani, former president of emerging businesses and global CIO of Merck, and former president and co-founder of Veeva Systems, Matt Wallach.

“In order to dramatically lower the cost and increase the speed of clinical trials, the industry must take a new, digital-first approach,” said Wallach who serves on Curavit’s board of advisors. “Curavit was founded by seasoned veterans with deep experience in that sweet spot where technology innovation meets process excellence so I’m proud to play a part in their journey to improve clinical trials.”

“This is an important milestone for Curavit and the industry’s continued momentum in digital therapeutics and decentralized approaches to clinical research,” said Joel Morse, co-founder and CEO of Curavit. “Traditional trial processes and timelines are insufficient – and they limit patient participation. New digital therapeutics are ideally suited for a DCT approach and will help improve access and drive new unique therapies to patients faster.”

The funding brings Curavit’s total capital raised to more than $8 million. Curavit has more than doubled its revenue in 2020 and 2021 and is on the same pace this year. More than half of its customer base are emerging digital therapeutics companies whose clinical research needs align with Curavit’s focus on virtual site services and DCT expertise.

“We are pleased to partner with Curavit on the next phase of their journey,” said Nate Lentz, Managing Partner at Osage Venture Partners. “The COVID-19 pandemic and rapid growth of digital therapeutics has driven a new digital model, where clinical trials are increasingly decentralized and require a new combination of technologies, services, and expertise not available in the marketplace. Curavit’s team and offering are well-positioned to fill this void and become the leading virtual CRO.”

Since its founding in late 2019, Curavit has accomplished key successes on its mission to bring clinical trials of innovative therapies to more patients in the cloud, including:

• Support for important research with digital therapeutics companies, including Swing Therapeutics, Lark Health, Curio, and Sana.
• Strategic partnerships with life sciences digital technology and data providers, including Ripple Science, for its direct-to-patient software platform; ixlayer, to provide easy access to clinical-grade diagnostic lab testing in DCTs; and 1nHealth, for digital patient recruitment and enrollment.
• Hired experienced industry leaders in top positions including Jay Collier as COO, Candice Del Rio as director of clinical operations, and Chris O’Shaughnessy as VP of business development.

In other news, Curavit joined the Digital Therapeutics Alliance, whose aim is to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics with patients, clinicians, payors, policymakers through education, advocacy, and cross-industry collaboration.

About Osage Ventures

Osage Venture Partners (OVP) is a venture capital firm located just outside of Philadelphia, PA. It partners with exceptional entrepreneurs, building the next generation of leading B2B software and tech-enabled services companies. OVP has consistently focused on this strategy since its inception in 2005, making over sixty investments in early-stage B2B companies over that time. For more information, visit OsageVenturePartners.com.

About Curavit

Curavit Clinical Research is a full-service, virtual contract research organization (VCRO), focused on designing and executing digital-first decentralized clinical trials (DCTs). Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, ultimately bringing trials to patients in the cloud. Curavit’s digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies more effective across representative populations. Visit www.curavitclinicalresearch.com.

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SOURCE Curavit Clinical Research

Curavit Clinical Research, a Scarsdale, N.Y.-based virtual contract research organization company, raised $5 million in Series A funding. Osage Venture Partners led the round and was joined by investors including Royal Street Ventures and Narrow Gauge Ventures.

There’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.
“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.

Traditional clinical trials are complex, but architecting a DCT from the ground up is even more complicated. And while nearly nine in 10 sponsors say they use some elements of DCT technologies in their trials, fully virtual trials are still rare. At a recent conference, one top-10 pharma executive said that while more than half of their trial site visits are virtual, no trials are 100 percent virtual.

One reason for this is because designing a DCT protocol requires highly specialized expertise. Sponsors are leaning into the decentralized approach to speed patient recruitment, increase access and diversity, improve efficiency, and capture real-world data, but are still developing protocol designs within a traditional framework. Expert DCT protocol designers, however, review trial designs to determine what aspects can be decentralized (and which cannot) and the best way to decentralize those elements. They factor DCT considerations into the process from the beginning, instead of shoehorning digital elements into the trial later or superimposing them over traditional designs.

The best resources are experienced in clinical research, the therapeutic area of the trial, and DCT technologies. These experts know how to allocate the right DCT resources to allow for maximum patient flexibility during the trial. For instance, a lot of calendaring is often involved in planning a DCT since the patient is not tied to a specific location. It becomes critical to ensure that there are enough calendar slots for televisit appointments at optimum times for patients. A DCT protocol design expert will take all resource considerations into the design, thinking ahead about what can be done by a coordinator instead of by a clinician or registered nurse and other ways to optimize staffing.

Patient recruitment is notoriously time-consuming, but many technology-enabled firms leverage solutions specifically for a DCT. For example, one patient recruiting firm targets potential patients on digital channels using sophisticated targeting, patient-centric recruitment, and technology. Once a patient clicks on an ad, they are taken to a self-service landing page with more info about the trial and self-screening questions. If the patient passes, they can immediately schedule a live screening call, eConsent, and enroll in the trial.

One virtual CRO specializing in DCTs collaborated with this patient recruiting firm on a trial of an investigational DTx for chronic cardiovascular disease. Through targeted ads on key digital channels (i.e., Google, Reddit, Facebook, Instagram), the CRO recruited 50 patients in 10 days, surpassing the sponsor’s originally estimated four-week timeline. In addition, 39 percent of patients who clicked on an ad completed the pre-screen form – again, beating a projected 24 percent completion rate. In total, the CRI and the patient recruiting firm recruited, consented, and enrolled 150 patients in just 58 days.

“Most recruitment methods miss opportunities to enroll patients, whether in finding the right people or communicating the opportunity correctly. Expert recruitment processes coupled with technology-activated enrollment at the site and CRO levels fill trials faster with less friction,” said Dan Brenner, CEO and founder of the patient recruiting firm. “Digital recruitment allows more patients to be enrolled in the right trials, seamlessly. It breaks down the barriers between patients and studies, increasing access for more patients.”

One independent software company optimizes the use of data to digitally recruit, screen, and consent patients in DCTs. With access to 350 million lives of anonymized medical records globally, and 200 million lives of anonymized claims data in the US, the firm uses a data science-based approach to target patients across a large geography.

“In DCTs, there’s a longer-term opportunity to marry enrollment and operational data to continuously learn and refine the patient recruitment and enrollment process,” said Matt Walz, its CEO. “How else can we use this data to improve trials? For instance, this data could inform protocol development so that sponsors can better assess how inclusion/exclusion criteria might impact enrollment. All this data can improve how we work with patients.”

In the end, whichever partner supports the enrollment process, data must be aggregated on a single platform for a seamless site and patient experience, and as an opportunity for continuous improvement. “DCTs expand access to patients who live a distance from academic centers, but they can also add burden,” Rosenberg continued. “For instance, patients must decide about each visit: Does someone come to their house, do they stop at a CVS [pharmacy], or go to the clinic? It is important to consider the impact of this new experience on patients. DCT technology enables us to survey patients in real time and then find ways to alleviate any unforeseen issues.”

The global remote patient monitoring market is projected to be worth over $1.7 billion by 2027, up 128 percent from 2021, and the increased use of a decentralized approach could push those numbers higher as DCTs require clinical-grade medical devices. Hundreds of devices already exist that capture digital biomarkers including sleep patterns, heart rate, and blood pressure. For example, continuous glucose monitors remind diabetes patients to take their insulin while allowing clinicians to monitor their disease.

In addition to these remote medical devices, DCTs can now incorporate convenient, remote lab testing with an end-to-end health testing platform. By making health testing easy for patients in a DCT, specialized firms help sponsors improve completion rates and likelihood of patient retention for the duration of the trial. One CRO partnered with such a firm for a fully decentralized trial for an investigational digital therapeutic for fibromyalgia. The firm’s health testing solution helped speed enrollment for the 12-week trial by 10 times over a traditional trial model.

“Lab testing is an integral part of most clinical trials but can compound patients’ burden in traditional settings,” explained Pouria Sanae, the firm’s CEO and co-founder. “We reduce friction for patients and sponsors by simplifying the process and streamlining data collection on the back end for DCTs.”

Electronic patient-reported outcomes (ePROs) are another critical remote data capture tool frequently used in DCTs. Look for a partner that is focused on ensuring a frictionless patient experience.

“In a DCT, patients have a larger responsibility to report their experiences even if they can do it remotely. At the same time, there is less in-person bonding where the clinician can get to know the patient’s everyday user experience. That is why it is so important to provide them with not only intuitive interfaces, but also concierge-like support throughout the trial,” Rosenberg explained.

How new tools are helping companies find and keep cancer patients in clinical studies.

Oncology treatment is improving at a rapid clip, so for people with advanced cancer, a clinical trial may offer new hope when other options have fallen short. But cancer patients still aren’t signing up — a problem that has vexed the industry for years. It’s estimated that fewer than 5% of cancer patients participate in clinical trials, most of them after they have already tried another treatment first.

But trial participation can bring rewards. A study in the Journal of the National Comprehensive Cancer Network found that while only 0.01% of the 12 million patients in the National Cancer Database enrolled in a clinical trial as a first-line treatment option, those that did had better outcomes than non-participants, although they also tended to be younger and healthier than the typical cancer patient.

To help more patients take advantage of these opportunities, organizations are testing new technological tools and focusing on convenience to boost enrollment and retention, as well as diversity.

One of the primary reasons cancer patients don’t enroll in clinical trials is perhaps the most obvious — they’re unaware trials exist, said Dr. Arturo Loaiza-Bonilla, co-founder and chief medical officer of Massive Bio, a New York City-based technology company using an AI-driven platform to match oncology patients with clinical trials.

Dr. Arturo Loaiza-Bonilla, co-founder and chief medical officer, Massive Bio Permission granted by Dr. Arturo Loaiza-Bonilla

“Most patients don’t have any idea what their options are,” he said. Even when a patient is interested in participating in research, determining which trial is right for them is often a substantial hurdle. Oncologists often don’t have the time to pore through options to find the right match. It can easily take up to an hour to go through all the criteria and data to search for a trial for one patient, Loaiza-Bonilla said. Some larger practices may have research coordinators to navigate this process, “but in a community practice, you don’t have that luxury, (and) you don’t have that person or expertise,” he said.

Oncology trials typically require patients to meet very restrictive participation parameters, ranging from the genetics of their cancer to the type of treatments they’ve previously undergone.

“Getting into a clinical trial for oncology is extremely challenging because there are so many criteria required,” Loaiza-Bonilla said.

Finding the right match takes an intensive approach, and as a result, many patients miss out.

“It has to be almost like a real-time activation for the patient. And if there’s no system to do it in real time for you, no one’s going to help you,” he said.

There are also emotional challenges and logistical barriers to contend with, said Candice Del Rio, director of clinical operations for Curavit, a virtual CRO that operates decentralized clinical trials. When a patient receives a cancer diagnosis, they are already overwhelmed, which may make them reluctant to take on additional treatments. She saw this firsthand as a nurse working with participants in oncology clinical trials. For patients still processing that initial shock, the idea of participating in research may seem like an additional burden.

“They may say, ‘Look, I just got to the hospital. I’m overwhelmed. I just need some downtime. I don’t know that I want to do anything extra. I just kind of want to stay the course,’” Del Rio said.

Organizations need to take steps to address these barriers if they want to increase enrollment.

Massive Bio is tackling the problem by enlisting tools to help patients more easily find the right trial.

“We founded the company with the goal of making clinical trials accessible for all cancer patients no matter where they are, and using technology at scale to make it work,” said Loaiza-Bonilla. “The space is already crowded by a lot of people saying we’re going to try to solve the problem, but there’s no good engine that’s able to connect the dots, and that’s what we’re aiming for with the company.”

Massive Bio’s AI-driven technology, the Deep Learning Clinical Trial Matching System (DLCTMS), pairs patients with existing trials in the ClinicalTrials.gov national database by combing through medical records to find the most clinically appropriate options based on the specifics of their cancer, including biomarker data. The company’s platform, which has onboarded 100,000 cancer patients to date, also includes other factors in its algorithm, such as the trial location, the patient’s insurance coverage and social determinants of health, Loaiza-Bonilla said. It ranks up to 100 exact and partial matches.

“We’re able to in 17 seconds match you to all the trials available in real time,” he said. Getting this information quickly is crucial because all too often a patient might find out too late that they were a match for a particular trial that has ended enrollment.

The system can also flag potential trials the patient might qualify for down the road if their condition changes, Loaiza-Bonilla said. “We are basically putting together a list of options that you can activate in real time,” he said. “The nice thing about it is that if you are on our platform from the beginning, we can help you across your journey.”

The goal is to help more people — and importantly a more diverse group of people — participate. Increasing broad participation in research has become even more crucial in light of FDA guidance aimed at increasing diversity in clinical trials, Loaiza-Bonilla said.

However, simply getting patients into trials isn’t enough — organizations need to retain them, Del Rio said. This is where decentralized trials can excel.

Candice Del Rio, director of clinical operations, Curavit Permission granted by Candice Del Rio

Patients with cancer are already dealing with a lot and need trial options that more easily fit into their lifestyle. For instance, many patients Del Rio has worked with needed to travel from other states or even other countries to participate in a study, making the process difficult and expensive and, in some cases, requiring patients to find temporary housing. Decentralized trials can make the process easier on patients by allowing them to participate from home, requiring fewer site visits.

One reason people running clinical trials hesitate to embrace a remote option because they have less in-person contact with patients, Del Rio said. But remote trials can also offer advantages when it comes to tracking patient health in real time.

“You can get quicker notifications. Sometimes in a clinic, we wouldn’t know that someone was experiencing an adverse event for two weeks until they actually came into the clinic,” Del Rio said.

But remote monitoring allows researchers to quickly identify when something is off and respond quickly. This can also improve retention, she said, because a patient with a new symptom can get immediate help, which might otherwise lead them to abandon the trial.

When using a decentralized model, however, it’s important to incorporate some flexibility in your trial design, Del Rio said. For example, while technology can be more convenient for some trial participants, it may sometime be challenging for others. Providing options can help.

Overall, improving enrollment and retention in oncology trials is crucial.

“Trials are part of the treatment. In a lot of ways, it’s the gold standard because drug developers are constantly trying to find better ways to treat an illness and cause fewer side effects and prolong longevity,” Del Rio said.

While there are many reasons why patients don’t participate in trials, improving enrollment often comes down to two simple factors — improving access and communication.

“If we use [our] tool at scale and reach out to those populations, we can hopefully make studies much more accessible to those populations that otherwise may have not been able to get them,” Loaiza-Bonilla said.

Digital enrollment for Lark Health’s Cardiovascular Disease DCT is sped up by using the “tapestry of the entire internet” through Curavit and 1nHealth.

Bringing your whole and authentic self to work is key. But what does that mean? And why is it important to have a personal leadership brand?

Experts say a brand conveys your identity and distinctiveness as a leader, communicates the value you offer, positions you as an industry thought leader and enhances your company’s brand. It can also give people a reason to follow you. As John Maxwell said: “If you think you’re leading, but no one is following, then you are only taking a walk.”

Your leadership persona should tap into your key attributes, talents and skills, but it might seem daunting to figure out what that brand should be. In a Forbes article, Devapriya Khanna, founder and CEO of 212° Brand Lab, laid out three brand builders: expression, emotional intelligence and executive presence.

First, “identify your values, vision, purpose and goals and package them into an authentic expression — so that your signature style and voice are unique, yet consistent.” Second, use self-awareness as the basis for emotional intelligence. Finally, she noted a “mindful and focused leader exudes leadership presence. Mindfulness can open the door to emotional connection with oneself and others.”

Take the time and put in the effort to create the persona that reflects your reputation as a credible and trustworthy leader who others will follow to achieve the big, hairy audacious goals for your organization.

For insights on how life science executives view their leadership style, we asked our 2022 PharmaVoice 100 honorees to identify the brands they relate most with. It’s no surprise that many pointed to top global brands — Apple, Google and Amazon — as inspiration. Interestingly, Patagonia was the No. 1 brand identified, with execs noting the company’s commitment to social responsibility, sustainability and community as values that resonate with them.

Here’s what some of the industry’s top execs had to say about their personal leadership brands.

Let’s face up to facts – there are challenges when it comes to clinical trials. Patient recruitment can be challenging and dropout rates can be high. Studies often put significant pressure on patients, who must juggle personal commitments with travel and trial participation.

Working with virtual CROs, explains Joel Morse, CEO at Curavit, could be one solution to the multitude of challenges companies face. “The traditional model for clinical trials has worked well for a very long time – and it still does serve a purpose,” says Joel Morse, CEO at Curavit – a virtual CRO. “However, it is inherently complex, with multiple sites, multiple and disparate patient recruitment efforts, and multiple places where data resides. The biggest challenge remains finding patients.”

Morse is passionate about the benefits of using digital tech to improve trials. For example, digital technologies can allow patients to participate in a trial regardless of location. For example, televisits allow patients to meet with the principal investigator of the trial from anywhere via a simple web link. “Patients can report how they’re doing to trial teams via electronic diaries rather than having to go into a doctor’s office,” he says.  “They can also handle the often long process of consenting to participate in a trial through e-consent applications and report on progress via e-PRO technology or electronic patient-reported outcome solutions.”

Morse also adds that technologies can enable companies to solve big challenges that are important to regulators and government, including diversity, health equity, and patient centricity. Digital technologies expand patient access to clinical trials across a wide geography because patients are no longer tied to physical trial site locations. Most trials take place at large academic institutions or academic hospitals in major cities, making it logistically difficult, if not impossible, for patients in rural or remote locations or without the financial means to take off work and travel great distances to participate. In fact, 70 percent of all clinical trials worldwide occur at just 5 percent of research sites, which primarily draw patients from populations within 40 miles of trial sites. Digital or DCT technology allows patients to participate from their own homes, eliminating the barrier of travel.

He says, “In my view, the most exciting potential of virtual trials is the ability to reach the large percentage of patients that are not historically exposed to clinical research. Virtual trials are also one of the rare instances where the regulatory environment is providing tailwinds to innovation by creating new guidelines for digital tech use in trials so they can certainly add value to trial recruitment and retention.”

But this does not mean that virtual trials are a panacea to all of the industry’s clinical trial issues. “Sometimes sponsors will try to incorporate digital technologies into a traditional trial that was not initially designed for digital. This has the unintended consequence of pushing new technology onto the trial sites without properly training them how to use it from the beginning, complicating and even slowing down the trial mid-swing,” Mose says.  “If companies designed trial protocols by collaborating with DCT experts from the beginning by looking at what aspects of the trial could benefit from decentralization and building those technologies and processes in early, you have the best results.”

But Morse is optimistic about virtual trials. But believes further progress will be necessary to see their widespread use. He says, “Currently too many trials shoehorn technology into a traditional design and end up increasing, not decreasing, patient burden. One day, digital technologies and processes will be an integral part of all trials, natively designed into each one.”

Digital enrollment for Lark Health’s Cardiovascular Disease DCT is sped up by using the “tapestry of the entire internet” through Curavit and 1nHealth.

“Undoubtedly, COVID-19 helped DCTs gain acceptance among sponsors, investigators and participants. But now stakeholders are seeing the incredible advantages of this new digital model to drive acceptance post-pandemic and beyond.”

Dr. Pam DiamondChief medical officer, co-founder, Curavit Clinical Research

The CRO and DTx specialist are joining forces to conduct a hybrid clinical trial of a potential digital therapeutic that is aimed at treating fibromyalgia.

The virtual format is catching on but has important limitations which make it unsuitable in certain situations.

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What can pharma companies do to ensure that clinical trials are conducted in the most efficient and patient-centric manner?

Clinical trials are integral to the drug development process. Yet, they are still affected by long-standing challenges, including poor recruitment and retention, the use of paper-based systems, and siloes among participating stakeholders. Though many in the industry agree that something must be done to address these challenges, practical steps are necessary to see real and lasting change.

The Medicine Maker brought together an expert panel to discuss the challenges affecting clinical and what can be done to make a difference.

Watch our video to learn more about the trends and challenges affecting clinical trials, including the growing prevalence of digital and decentralized trials, COVID-19 induced supply chain issues, and the impact the war on Ukraine is having on trials.

Participants:

Georg Schulz, EVP of Clinical Services & Senior Director of Corporate Development at Tanner Pharma Group, a global provider of pharmaceutical solutions.

Georg has more than 25 years of senior executive experience in the pharmaceutical industry. He has a proven track record in strategy design and execution, organizational development, supply chain management, international air and sea transport, and cold chain management for pharmaceutical products.

Dave Hanaman, President, Co-founder, and Chief Commercial Officer at Curavit

Dave co-launched Curavit over two years ago. He has spent more than a decade as an intelligence officer in the US Navy and was co-founder and director for 22 years of C3i, a global healthcare technology company, until it was sold.

Claire Marsden, VP, Digital and Decentralised Solutions at Medable

Claire has worked in the industry for over 25 years. She has worked across all phases of clinical development in companies including GSK, Pfizer, Novartis, Bayer Alnylam, and IQVIA.

Andrea Valente, Chef Executive Officer at ClinOne

With over 20 years of industry experience, Andrea joined ClinOne after serving as Chief Operating Officer at Medable. She has an extensive background in life sciences technology product development, delivery operations, customer loyalty, and merger and acquisition strategy.

Pam Diamond, MD

Digital therapeutics (DTx), the use of software-based interventions to prevent and treat disease, is one of the biggest areas of growth in life sciences. CB Insights reported that 2021 funding in the digital health industry grew 79% over 2020,{1} and the global DTx market is projected to hit $13.1 billion by 2026, up from $3.4 billion in 2021.{2} Many say digital therapeutics will re-write the future of healthcare.{3}

The DTx industry isn’t just aspirational. Studies show improved outcomes from DTx, either alone or in conjunction with conventional therapeutics, in a broad range of indications, including cancer, ADHD, asthma, schizophrenia, and insomnia. Some examples of products include video games to treat mental and behavioral health issues; a platform that incorporates neurological music therapy, sensors, and artificial intelligence to help patients who have suffered a stroke or other neurological disorder to rebuild motor skills; and a smartphone app that can conduct electrocardiograms anytime, anywhere.

Background

While exciting, this is still unchartered territory. Regulatory lines are often blurry between prescription DTx, non-prescription DTx, and combination digital therapeutics/traditional medication. It’s worth noting, however, that the U.S. Food and Drug Administration (FDA) has demonstrated its commitment to supporting digital health technologies through the publication of multiple guidance documents and the launch of the Digital Health Center of Excellence, which aims to connect and build partnerships to accelerate digital health advancements, in September 2020. In April 2021, too, the FDA loosened regulations surrounding approval of digital mental health tools to hasten their time to market.{4}

Even so, not all DTx manufacturers choose to seek FDA approval, but they all need to prove efficacy through clinical studies for payers to consider coverage and consumers to consider purchase. Regulatory approval is not always the end goal—or at least, not initially.

AstraZeneca, for instance, has designed a rigorous and low-patient-burden digital therapeutic to monitor metastatic breast cancer patients. The prescription DTx, which is currently being tested in clinical trials in 23 countries, was developed using insight from a review of medical literature, pulmonary and breast cancer experts, technology review, and real-world evidence gathered through conducting a deep cohort analysis of approximately 500 patients in U.S. health systems.{5} The therapeutic’s aim is to monitor patients’ symptoms and vital signs and, based on algorithms and expert rules, alert a physician as to how well the patient is doing on the treatment to maximize both safety and outcomes.

“Regulation will differentiate between a fitness app a consumer can simply download, with no regulation required, versus something that is scientifically proven to have a direct impact on someone’s health condition or outcome, which a doctor may prescribe,” said Cristina Duran, chief digital health officer for AstraZeneca, in a statement. “In a few years, I think we will see that shift to it being commonplace for your doctor to prescribe a digital therapeutic, a medication, or both.”

Indeed, it’s a complicated and quickly evolving arena in healthcare.

On top of the current regulatory limbo, DTx manufacturers face many of the same clinical trial challenges as traditional drug makers, including those tied to patient recruitment and retention, quality of data, and costs. They also must carefully consider the unique technical security concerns of an all-digital therapeutic and face strategic decisions around either provisioning smart devices or leveraging a “bring your own device” (BYOD) policy. At the same time, clinical trial models are rapidly evolving, adding further complexity for companies working to develop innovative digital therapeutics in a post-pandemic environment. Decentralized clinical trials (DCTs) are becoming a preferred model for research in biopharma and offer even greater benefits to companies conducting studies on digital therapeutics.

Wave Neuroscience, a medical device manufacturing company that specializes in designing software and physics-based personalized brain-based interventions, is moving toward more decentralized clinical trial designs. “DCTs can improve patient recruitment and retention by reducing burden and eliminating geographic barriers,” explained Dr. Erik Won, president and chief medical officer of Wave. “This also results in a more representative sampling of the population, such as patients from rural areas who often don’t have access to major institutions.”

Dr. Won continued, “DCTs can also increase the quality of data by minimizing the Hawthorne Effect—where individuals modify an aspect of their behavior in response to their awareness of being observed, also known as ‘white coat syndrome’—because patients are in their home environment.” Finally, DCTs can be more cost-effective, he added.

When Stars Align: DCTs and DTx

Fundamentally, a DTx is software rather than a pill or injectable, so there is no distribution or administration of medicines. There are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards—plus endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies whether the goal is regulatory approval or consumer and payer confidence.

In all cases, though, the unique advantage is that the DTx being studied in a trial is also the data collection device, so manufacturers often don’t need extra technologies like an electronic patient-reported outcome (ePRO) system to capture data in a clinical trial. It’s all in one, and this can result in big cost savings.

For example, Texas A&M and Wave Neurosciences are conducting a hybrid clinical trial on the safety and efficacy of magnetic EEG-guided resonance therapy to treat post-traumatic stress disorder (PTSD). This therapy uses transcranial magnetic stimulation, which has been cleared by the FDA for treatment-resistant major depressive disorder, obsessive compulsive disorder, and nicotine cessation. With this algorithm-driven therapeutic, a personalized treatment is delivered via conventional (in-person) appointments. Screening and follow-up visits, in which participant-reported data are collected, take place virtually to the extent possible.

“America is experiencing a crisis in mental health,” said Dr. Won. “Software- and physics-based personalized therapeutics are a modern, non-pharmaceutical, non-invasive option to help in this area. We are testing our therapeutic with an eye to pursuing an FDA marketing approval for the PTSD indication. We are exploring the decentralized trial model to introduce greater flexibility and speed into our research efforts.”

Best Practices for Designing DTx Trials

With the quickly growing and evolving DTx market, and the complexities associated with clinical research, here are five considerations for decentralized trial design:

1. Know your regulatory roadmap before embarking on a trial.

Because the regulatory pathway for digital therapeutics is not as clear-cut as it is for traditional investigational drugs, it is critical to outline your regulatory roadmap before recruiting the first patient. Feasibility studies can be a good place to start, especially to help map out an expansion plan down the line. Some important considerations also include how future versions of your DTx product will be tested, benchmarked, and evolve over time.

“It is always best to seek meetings with the FDA’s device division [the Center for Devices and Radiological Health] early, and often,” said Dr. Daniel Karlin, chief medical officer at MindMed, a clinical stage biopharmaceutical company developing novel products to treat brain health disorders. Dr. Karlin is also the lead medical advisor to the makers of the first and only FDA-cleared, prescription DTx that improves sleep in adults 22 and older with nightmare disorder or nightmares related to PTSD.

Dr. Karlin continued, “It is easier for DTx providers to secure meetings with the FDA because digital therapeutics are typically less biologically complex and therefore pose less risk. Request a meeting at the start of your development efforts to agree on the claims you plan to make based on the indication for use, and to establish what related evidence will satisfy the FDA. This is fundamental. Also, seek institutional review board [IRB] clearance on anything that could conceivably be research-related before you bring an experimental device to humans for studies.”

Of course, regulatory approval—while often considered the ultimate validation for the safety and efficacy of a drug or device—isn’t the only reason for conducting clinical research, especially with DTx. Health economic outcomes and human factor research are often equally important for product adoption. Even in the digital realm, real-world function and outcomes are important to create products that lead to meaningful outcomes for patients. “All manufacturers want payers and patients to be confident in our product’s efficacy, safety, and economics,” added Dr. Won.

For instance, some DTx products that have minimal risk may not require regulatory approval but are just as valuable as those that do. Decide if regulatory approval is on your short-term or long-term roadmap and design the trial accordingly. If it is not, then there is greater flexibility in study design.

2. Map out an immediate and long-term commercial strategy.

Given how quickly the DTx marketplace is evolving, the best that can be done may be to sketch out a preliminary commercialization strategy that has plenty of leeway to deviate from that path, if necessary. For instance, if your therapeutic will not be intended for regulatory approval, you may need to focus on a consumer strategy that focuses on everyday wellness. If you know this up front, you can design your clinical trial around endpoints that mirror your target consumer’s biggest pain points. However, if your end-goal is to develop a DTx that will be used in combination with an FDA-approved drug, then you will need to design your trial based on endpoints relevant to that drug maker’s target patient population.

3. Carefully consider and incorporate protections against technical security breaches.

Data security and privacy are crucial for all clinical trials, but especially when studying DTx that are 100% tech-driven and, therefore, potentially vulnerable to more issues. One of the most important decisions that needs to be made up front is whether the protocol will strictly enforce a BYOD strategy (which could prevent some patients from participating) or require the sponsor to provision devices to all participants (which could be cost-prohibitive)—or some combination thereof. Each option comes with different security considerations, so decide this up front.

Regardless of device strategy, all data collected on the smartphone will need to be encrypted and then sent to a secure central platform in the cloud that follows all regulatory compliance parameters. Additionally, invest in a platform provider or tech-enabled CRO that maintains a strict security perimeter, including a “zero-trust” architecture with individual logins and audit trails for everyone who has access to the data every time they log in or out—this, on top of the digital therapeutic app’s security standards.

4. Develop digital endpoints that are fully validated and meaningful to patients.

Traditional medicine trials measure against accepted endpoints that are validated in accordance with standards set forth by the IRB and regulatory organizations. However, DTx studies are typically measuring novel digital endpoints that are different for each DTx app and do not have a history of vetted benchmarks against which to be validated. Even so, reviewers will need to ensure that the novel endpoints aren’t bogus, and this can require some extra steps and creativity.

In many cases, endpoint validation in DTx studies requires a comparison to something similar that has been already validated or the use of previously vetted ratings scales. For example, when conducting a depression study, the DTx sponsor may first administer the Columbia-Suicide Severity Rating Scale—a suicidal ideation and behavior rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh, and New York University—to potential participants at screening. The patient’s score can be the baseline for the study, so if the DTx is efficacious, that score should drop and serve as a validated digital endpoint for symptoms of depression.

Similarly, DTx studies may leverage ePROs to administer quality-of-life questionnaires compared against prior research already accepted and validated by the IRB and FDA. Another way to validate endpoints in a decentralized DTx trial is to incorporate an initial site visit with a clinician who can compare the measurement of, say, a wearable device against an equivalent onsite, hospital-grade machine. Doing so can prove the wearable is as valid a measuring tool as another.

Finally, as important as endpoint validation is patient validation—in other words, identify the measurements or endpoints that are meaningful to patients. For example, with Fern Health’s digital musculoskeletal platform, the company shifted the focus of pain management from pain relief to functional restoration. Early on, the company found that functional pain endpoints are more important to patients in the long term than pain relief alone and made that critical adjustment.

5. Assess the use of DTx placebos or sham apps early and often.

In a DTx clinical trial, dummy or “sham” apps are often used as a control in comparison to the actual treatment or intervention app—like a placebo pill used in a randomized control trial. There are unique considerations in using sham apps, however, including the potential for an unintentional placebo effect.

Here is the challenge: It is very difficult to make a sham app similar enough to the real one, which means patients often suspect that they were not assigned to the treatment arm. In addition, patients who do interact with the sham app can experience a placebo effect that negatively skews study results. For instance, patients in the treatment arm of a study would typically show significant symptom improvement compared to the non-treatment arm, but when using a sham app, that disparity is not as dramatic.

The FDA has not yet ruled on whether placebos or “sham” apps must be used in DTx trials, but the agency often prefers a sham control. DTx companies that opt not to use a sham control will need to work very hard to find creative ways to design an FDA-acceptable trial that won’t be criticized—even then, there is no guarantee that the FDA will accept the results.

“It is highly unusual to view sham controls as unnecessary in clinical trials,” said Dr. Karlin. “Not only do regulatory bodies prefer sham-controlled evidence in digital therapeutics studies, but also clinicians. Reluctance to use sham apps will cause companies to struggle to get both FDA clearance and physician buy-in, which is critical for commercial success with patients.”

Dr. Karlin’s team for the PTSD DTx leveraged a sham control on a wearable device that, rather than buzz when detecting a nightmare, simply recorded it. “When we assessed the reliability of our blind through a survey of our trial participants, we found that most did not know whether they were using the real therapeutic or the sham,” he noted. “This helped validate the research because it meant that we could reliably compare the active intervention with the placebo for more meaningful results. Randomization and sham control are not magic bullets, but they’re the best options we have right now.”

As the Digital World Turns…

There’s still a lot to be learned in the DTx market, but they are here to stay with growing reliance, trust, and adoption of digital health products. COVID-19 pushed researchers to lean into the decentralized model for research, and the pandemic has simultaneously fueled a growing need for DTx products—an ideal marriage of process and product. Remaining flexible and open-minded will be critical to succeed in this evolving and exciting area—as the digital world turns.

References

1. Taylor NP. 2022. Digital Health Funding Jumps to New High. MedTech Dive. See full resource here.
2. Market and Markets report. 2021. Global Digital Therapeutics Market Projected to Reach USD $13.1 Billion by 2026. ReportLinker. See full resource here.
3. Taranto B. 2021. The Growing Power of Digital Healthcare. TechCrunch. See full resource here.
4. Staff report. 2021. DTx Trends and Companies to Watch in the Growing Digital Health Industry. Insider Intelligence. See full resource here.
5. Galbraith S. 2021. Digital Therapeutics: Augmenting Patient Outcomes. AstraZeneca. See full resource here.

Digital technologies have had profound effects on how we communicate (i.e., smartphones), share information (i.e., social media), and create (i.e., 2- and 3-D printing). Now, they are having an impact in healthcare, too. The latest (and arguably most exciting) example is digital therapeutics (DTx): medical treatments to address health conditions via a combination of software and communications. DTx are in use or being tested for a growing list of diseases and conditions: Type 2 diabetes, congestive heart failure, obesity, Alzheimer’s disease, dementia, asthma, substance abuse, hypertension, anxiety, depression, and more.

Digital Health or Digital Therapeutics?

Researchers and policymakers make distinctions among digital health (the overall category of health-related interactions), prescription digital therapeutics (apps or tools that have gained regulatory approval), and software used as an adjunct to guide a healthcare provider’s treatment of a patient (software as a medical device, or SaMD, regulated in the US by the FDA Center for Devices and Radiological Health). There are overlaps from one category to another but, in nearly all cases, a rigorous evaluation in the form of a clinical trial to clearly demonstrate the impact of the digital technology is needed, even when regulatory approval is not the end goal.

“Digital solutions have a variety of intended use cases which drive their approval pathway, and they are equally valuable and important depending on the end goal,” said the head of digital health, oncology R&D at a top-10 pharmaceutical company that has digital therapeutics in development across therapeutic areas. “Whether the digital therapeutic is for consumer health assessment or in a trial or routine care setting, following the guidance around use cases and a carefully developed measurement framework is critical to ensure scientifically rigorous and responsible assessment of a patient’s health status.”

Improving preventative care and chronic disease management has helped slow the process of aging. In the United States, the 65 and older population has grown by over a third in the past decade, and the number of adults aged 85 and older is expected to nearly triple by 2060. Yet, living longer comes with risk. Genetic mutations are generally managed by the body’s ability to perform necessary repairs. However, with increasing age, the number of mutations also increases, which can give rise to cancer. Indeed, people aged 67 and older represent half of cancer patients and cancer is the second leading cause of death for people aged 85 and older. We owe it to ourselves to do something about this.

While the primary purpose of research is to learn, clinical research also seeks to advance treatments if possible. Many oncology patients, particularly those with aggressive disease, know that access to the most advanced medicines may entail being a part of a clinical trial. In comparison to other disease groups, cancer trials have the fewest age caps for enrollment. This is partly because, unlike chronological age or the number of years alive, physiological age (or how old one is due to genetics and lifestyle) is a better indicator of a patient’s ability to tolerate harsh treatment regimens and related toxicities. Older age is generally associated with reduced organ function and poorer performance status scores, which are risky for institutions ill-equipped to manage therapy-induced complications. Furthermore, sponsors would prefer to minimize instances of negative effects from their drugs; in response, many cancer clinical trials have an upper age limit of 70 to 80. Disappointingly, the median age of cancer participants enrolled in trials is an average of 6.49 years younger than that of patients with the same cancers not enrolled in trials. In essence, cancer patients who are granted entry to clinical trials are typically younger, fitter, and likelier to tolerate research regimens, while older, higher-risk patients are left without immediate access to potentially life-prolonging therapy. The very people who are most likely to require treatment with innovative therapies will not reap the benefits of a rigorous testing process.

Fortunately, these same patients are widely adopting technology: More than half of US adults age 65 and older own smartphones and 75% use the internet. Cancer patients are more likely to complete web-based questionnaires than paper-based forms. Oncology researchers often consider in-person follow-up essential to ensure safety and wellness in study participants. But this begs the question of whether the risk of missing an in-person observation outweighs the risk of transporting the infirm. Unless patients are so sick as to require hospitalization, are they not better off in the comfort of their homes, avoiding communicable infections for at least part of a trial’s duration?

One study shows that cancer patients who are offered the telehealth option improved communication with their providers, had 38% fewer hospital admissions and 31% fewer readmissions, and improved quality of life. This is significant because older cancer patients prefer quality of life over length of life. For cancer patients, untreated symptoms like gastrointestinal upset and pain can turn serious rapidly. Digital in-home symptom tracking tools for patients receiving chemotherapy offer pattern-recognition, severity detection, and real-time symptom management which reduce symptom burden by 43%, decrease the number of emergency room visits, and mitigate costs.

Advances in technology allow us to play 4-D video games, turn down our home’s heat while traveling in another state, and print objects from a personal-use device, yet we go about clinical research in an archaic fashion. Investment in our health is surely as important as investment in fun-to-haves, and yet trial participants remain too familiar with paper surveys, long clinic visits, and delayed responses to adverse events. If there is ever a time for clinical research to get up to speed with technology-driven industries, it’s now. And elderly cancer patients must be the focal point of this endeavor.

There are already pioneers committed to this mission. The Collaborations in Health, Aging, Research, and Technology (CHART) at the University of Illinois at Urbana-Champaign has constructed a research-focused “smart home” to learn how the elderly may benefit from using smart appliances, assistive robotics, and home sensors. Tools like these may seem like a luxury to some but could be essential for those who would otherwise rely on caregivers to meet basic health needs and achieve a sense of normalcy. If access to these tools improves someone’s ability to participate in a clinical trial–because they can now do just about anything a younger, healthier person can do, just differently–industry sponsors should pay attention. One cannot discount the cost of owning smart devices and tools. Insurance coverage and reimbursement programs could make a big difference in affordability. Traditional (less new) technology often carries the benefit of reduced or no cost for use. Examples include phone applications, wearable devices, and voice-operated mobile assistants.

It is important to note that some barriers to maximizing technology use in the elderly do exist. For instance, difficulty reading from small screens, manipulating voice-activated software, and understanding evolving terminology are a few. But these challenges are not insurmountable. Understanding how the elderly utilize technology is a step in the right direction. By engaging multidisciplinary research teams in rich discussions with patients and their caregivers, the potential for developing truly smart, customizable technology is vast. It may not be long before augmented reality glasses can be used for easily viewing and completing drug diaries as well as participating in virtual health visits. An automated call to a clinician when an in-dwelling catheter detects low levels of circulating red blood cells may be just around the corner. A bit of foresight, some creativity, and an incorporation of technology can allow investigators to spend more energy focusing on collecting and generating meaningful remote follow-up data that eventually improves treatment access and outcomes for elderly patients.

At present, we can only hope that our parents, grandparents, and even our future selves, if faced with cancer, will thrive in old age–not alone, but with the companionship of our aging loved ones. We can make this a reality by applying technology and thinking “outside of the (clinic) box” to bring our cancer clinical research to our elderly cancer patients.

The more experience clinical research professionals gain in conducting full or hybrid (onsite/offsite) decentralized clinical trials (DCTs), the more advantages beyond simple economics and convenience for patients they are realizing from the tactic, contributors to the next issue of ACRP’s Clinical Researcher journal suggest.

For example, in her forthcoming column on “Unique Considerations in Designing Decentralized Trials for Digital Therapeutics,” Pam Diamond, MD, cofounder and chief medical officer of Curavit Clinical Research, quotes an expert from the medical device arena as saying that DCTs can increase the quality of data by minimizing the Hawthorne Effect—where individuals modify an aspect of their behavior in response to their awareness of being observed. This phenomenon, also known as “white coat syndrome” in healthcare situations, is thought to be less of a factor when patients are in their home environment.

Diamond goes on to write that, “Fundamentally, a digital therapeutic (DTx) is software rather than a pill or injectable, so there is no distribution or administration of medicines. There are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards—plus endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies, whether the manufacturer’s goal is gaining regulatory approval or consumer and payer confidence.”

Meanwhile, in a column on “The Ecosystem of Decentralized Clinical Trials: It Takes a Village to Modernize Care,” MaryAnne Rizk, PhD, chief strategy officer for Medable, notes that, when “companies coordinate their efforts to design and execute DCTs, sponsors, investigators, and patients see the benefits. A connected ecosystem of DCT collaborators can streamline operations and data collection and resolve interoperability challenges. With a coordinated approach, the industry will accelerate this new model to make better medicines faster, safer, and more effective for every biology around the world.”

Rizk adds that, to navigate the new waters of DCT delivery, leading organizations are coming together to create a network of “best-of-breed, trial-enablement providers” that “includes contract research organizations, traditional and nontraditional investigator sites—including new retail pharmacy sites—and leading data and technology services providers” responsible for a range of trial support technologies and processes.

Still, Kristin Mauri, solutions services director for Remarque Systems, in her column on “DCTs: Key Considerations for Small-to-Midsized Biotech and Biopharma Companies,” looks at how the DCT trend may seem daunting for companies that feel that “the risks of treading this new territory—an area with complex data management demands and no clear regulatory guidance—outweigh the potential rewards.” However, Mauri adds that if some companies feel that DCTs are outside their comfort zone and budgets, that is not necessarily true.

As just one consideration, Mauri notes how, “untethered from sites, DCTs can recruit from anywhere, which often leads to faster enrollment and fewer screening failures. Further, that same geographic freedom also means fewer sites, thus fewer review boards, potentially lower regulatory costs, and greater flexibility around protocol amendments.”

Further, in his column on “A Hybrid Approach to Decentralized Clinical Trials,” Clincierge Cofounder and CEO Scott Gray writes that, “Moving forward, we must continue to assess the value provided by DCTs in ensuring patient experience and safety remain of the utmost priority. We should continue to build upon what has been learned since the onset of the pandemic. It is up to clinical trial stakeholders to determine the best approach for balancing the needs of patients and their caregivers against the goal of contract research organizations and pharmaceutical study sponsors. Whether that means a decentralized, traditional, or hybrid course, prioritizing clinical trial patients’ health and best interests ultimately encourages higher enrollment, increased retention, and more robust data collection results.”

The June 2022 issue of Clinical Researcher, with these columns and other content touching on DCTs and data analysis for trials, in addition to three peer-reviewed articles, will go online on or around June 21 on the ACRP website.

DCTs are also the focus of a recent whitepaper on Decentralized Clinical Trials: Perspectives for Clinical Research Professionals developed by expert members of the ACRP Fellows and sessions presented at April’s ACRP 2022 conference (such as by thought leaders from Clario and Northwell Health), the recorded contents of which will soon be available in the Online Conference Library.

While digital therapeutics (DTx) companies are extremely optimistic about the promise of software-based interventions to prevent and treat diseases, they are still navigating unchartered territories around the best practices for clinical research, including patient recruitment and retention, quality of data, high costs, and uncertainty around regulatory guidelines.

At the same time, clinical trial models are rapidly evolving, adding further complexities. But one thing DTx companies do agree on is that the decentralized clinical trial (DCT) model is key to overcoming their biggest hurdles and improving the entire clinical research process.

A Patient-Centric Approach

Patient retention and engagement have long been challenges in clinical research, but DCTs have had a uniquely positive impact on DTx studies. DCTs make trials more accessible to participants who live far away from study centers. Opening studies up to more participants, optimizes the patient pool and reduces the need to over-enroll based on anticipated attrition or drop-out to improve cost efficiency.

Dr. Mike Aratow, Co-founder and Chief Medical Officer of Ellipsis Health, a DTx company that developed the first voice vital sign to quantify and manage depression and anxiety, explains, “A decentralized model not only aids patient recruitment because it removes many of the burdens associated with traditional trials, but it also makes it easier to reach underrepresented groups and those from a wider geographic landscape, providing real-world evidence and ecological validity. In traditional research, a significant amount of the medical data can’t be reproduced due to issues around patient retention and patient participation.”

Feel Therapeutics develops digital biomarkers and therapeutics for mental health using a proprietary wrist-worn wearable device. It monitors various physiological signals to extract insights on patients’ psychological and physical health. According to Feel CEO George Eleftheriou, “DCTs help optimize patient recruitment and improve engagement and retention. Wearable and digital technologies remotely measure endpoints while engaging participants in an unprecedented way and which naturally aligns with digital therapeutics that are intended to integrate into patients’ everyday lives. It is indicative that participants in our digital programs use our app for over 55 minutes per week.”

Reduced Costs

In 2020, Insider Intelligence predicted the global DTx market would hit $9 billion by 2025, but a year later sharply upped that forecast to $56 billion.¹ Despite this market growth, the DTx industry is still in its infancy with most companies considered startups with modest resources. Cost efficiency is central to their success—and another reason why a DCT model complements the DTx business strategy.

DCTs save costs, in part, by saving time. For instance, the single biggest time drain in clinical trials is patient recruitment, which can take up to 30% to 40% of the duration of the entire trial process. By streamlining this process using digital tools and expanding the geographic area for recruitment, DCTs have faster recruitment, and require less staffing and infrastructure. DCTs allow researchers to customize DTx trials based on exact needs, patients, and commercialization strategy.

Additionally, the technology needed to run a DTx trial is materially different from the technology for traditional trials. Much of the software needed for a DTx trial is already baked into the DTx app being studied, so many of the robust components required for traditional clinical trials involving prescription drugs are not needed. DTx companies can save substantially—reducing the costs by a factor of 20 or more—by cherry-picking just the technology needed to run the DCT.

New data backs up the value of DCTs. According to a 2022 study by the Tufts Center for the Study of Drug Development, which compared published benchmarks on trial cycle times and costs with data from more than 150 DCTs conducted by trial software firm Medable, decentralized Phase 2 studies are completed one to three months faster than traditional trials and the time savings yield a net benefit that is up to five times greater than the upfront investment required. Decentralized Phase 3 trials with similar time savings yielded a net benefit that is up to 14 times greater the upfront investment.²

Improved Data Quality

Decentralized trials enable DTx companies to collect real-world data direct from patients where they are most comfortable, which has a quantifiable impact on data quality.

Dr. Erik Won, President and Chief Medical Officer of Wave Neuroscience, a DTx company that specializes in treating brain disorders, explained, “DCTs increase the quality of data by minimizing the Hawthorne Effect—a reactivity in which individuals modify an aspect of their behavior in response to their awareness of being observed, also known as ‘white coat syndrome’—because patients are in their home environment. With a decentralized trial, we get the best of both worlds. We can use other mechanisms to ensure that patients are following protocols while ensuring compliance. For instance, we record EEGs using wearables and ask patients to complete simple online surveys.”

DCTs also enable researchers to capture data and endpoints directly within the digital therapeutic itself for seamless data capture and less potential for “lost” information.

“DCTs enable us to collect passive, continuous, and objective data from users 24/7/365 and move from episodic patient-reported outcomes to continuous data collection,” added Feel’s Eleftheriou. “This rich data provides real-world evidence and allows us to explore novel biomarkers or digital endpoints in neuroscience and other chronic conditions with a high prevalence of mental health comorbidities, such as multiple sclerosis, certain cancers, and cardiac problems.”

Regulatory Approval

DTx companies operate in a nebulous regulatory environment, even as the Food and Drug Administration (FDA) works to clarify requirements. For example, the FDA has demonstrated its commitment to supporting digital health technologies recently through the publication of multiple relevant guidance documents as well as the founding of the Digital Health Center of Excellence (DHCoE) in the fall of 2020.

Yet, the regulatory landscape is complex, evolving quickly and differently in each country. Regulatory approval is not always required to go to market, disincentivizing studies. Many DTx manufacturers are left to make decisions on their own on whether they choose to seek regulatory approval, depending on their commercialization strategy and often take a bifurcated approach—seeking FDA approval for one variation of their product and not for another.

Wave Neurosciences follows FDA guidelines for conventional trials while making adaptations in non-FDA studies to maintain regulatory compliance. These “bridge” studies are often smaller, faster, less expensive and designed to gather enough validated data to determine if taking the next step to an FDA-approval study makes sense. In these cases, especially, a decentralized model makes it much easier and faster to stand up a “bridge” trial for DTx companies looking to determine what the next best steps should be for their product and commercialization strategy.

The Perfect Pairing

Fundamentally, DTx products are software, so there are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards plus endpoints can be captured directly within the DTx application, making DTx studies ideally suited for the digitally enabled decentralized model.

Even so, much is still to be learned in the emerging DTx market. While COVID may have forced researchers to lean into DCTs and the pandemic continues fueling a growing need for digital therapeutics, this perfect pairing will only benefit the industry and society a whole.

References:

1. Insider Intelligence, “DTx Trends and Companies to Watch in the Growing Digital Health Industry,” by Staff (July 29, 2021). See full resource here.

2. FierceBiotech, “Not Just for a Pandemic: DCTs Pay Off Financially, a Study Shows,” by Gareth Macdonald (January 12, 2022). See full resource here.

A leader from the VCRO shares how far the industry has come with decentralized adoption, where opportunities for improvement exist, and what lies ahead.

While the pandemic knocked many clinical trial operations for a loop, the decentralized clinical trial (DCT) format has fueled a comeback since COVID-19’s arrival. Dave Hanaman (co-founder, president, and chief commercial officer of Curavit) spoke with Outsourcing-Pharma about progress made, lessons learned, and the road ahead.

OSP: How have decentralized trials evolved in the past two years?​

DH: The biggest evolution has been the adoption of decentralized clinical trials (DCTs) by sponsors that would not have considered them without the catalyst of the pandemic. Before the pandemic, DCTs accounted for only 2-4% of trials and were projected to increase about 10% over the next 10 years. The pandemic and lockdowns forced the industry to get creative.

While there was a feeling early on that the use of DCTs might decline when the pandemic was over, the benefits of the model and the continued threats of new COVID variants proved otherwise. Now the DCT market’s estimated value is a staggering $1.63b USD by 2027, an annual growth rate of 14.8%, according to Precision Reports.

Much of this growth over the past six to 12 months is a result of the exploding digital therapeutics (DTx) market and their adoption of DCTs. According to Report Linker, the global DTx market is projected to reach $13.1b USD by 2026, up from $3.4b USD in 2021. These DTx companies are bringing novel software-based therapies and diagnostics into the market and their business and delivery models line up almost perfectly with DCTs because of the way these trials are designed from digital-first principles.

When Lark Health decided to embark on its most recent decentralized trial with Curavit, a virtual CRO, its leaders saw the potential for a host of benefits.

According to OraLee Branch, the trial’s principal investigator and Lark’s director of clinical studies and research, a decentralized clinical trial (DCT) would be more patient-centric and convenient. It could boost efficiency, would likely be faster, and could help with recruiting a diverse population.

Lark joins an increasing amount of small to midsize companies now transitioning to DCTs, which provide solutions for a number of common logistical headaches.

It was also a natural fit for the midsize digital therapeutic company, which uses a cognitive behavioral therapy approach to create mobile apps aimed at managing and preventing chronic diseases, such as diabetes and hypertension. The apps’ features also include personalized coaching, and use artificial intelligence to help support lifestyle changes, such as weight loss, quitting smoking, or managing stress.

“I came to Lark from an academic background. I was a principal investigator and a full professor at various leading medical universities. So, I have a lot of experience in clinical trials and in managing decentralized, multi-site institutional trials,” Branch says.

For their upcoming study, which will test the use of a chronic disease prevention and management program, Lark wanted to enlist the help of other experts.

“We wanted a CRO who has had this kind of expertise, so that we can focus on what Lark does best, which is have great programs and great experiences for the user,” says Branch.

As an added bonus, they hope that having an outside CRO coordinating and managing data will bolster data integrity.

“We want this to be a high data integrity representation and the easiest way to do it is to have that external collection,” she says.

Here, Branch discusses how Lark plans to gain from using a DCT and how it is overcoming challenges associated with this approach.

PharmaVoice: What advantages do you hope decentralization will bring in terms of recruitment?

OraLee Branch: In conventional trials, which are typically brick and mortar or in-person trials, the people who end up participating are a select group. They are what you’d call a biased collection of participants. These are people who are willing and able to travel to the facility where the trial is conducted. People who join trials are sometimes more health conscious than the average person, or more likely to be from an urban versus a rural area. Participants also tend to be less diverse, or from different socioeconomic backgrounds than the general public. We want to remove that bias from the trial. That allows us to study people who are more likely to be the future users of Lark, so that the results that we’re obtaining are applicable to the general population. We want to make sure that we’re reaching the people who we know will be the users of our program.

Are there other benefits of a decentralized trial?

We are also hoping to connect a lot of fragmented information. We want to link laboratory results with clinical findings, and with the user’s every day well-being measures. That is why we really have our eyes on this decentralized clinical trial.

When Curavit Clinical Research launched in December 2019, the startup was looking to blaze a new trail in the clinical trial space. Quite simply, they added a “V” before the traditional “CRO,” and positioned themselves as the “first virtual contract research organization (VCRO).”

The timing could not have been more apt — or more of a challenge. The pandemic had supercharged the move toward decentralized clinical trials (DCTs), including virtual trials, and furthered already-strong regulatory tailwinds, Dave Hanaman, Curavit’s president and chief commercial officer, says. But it also created logistical challenges and upended the company’s planned roll-out strategy.

“We fully expected that the decentralized market, while small, was going to grow at a steady pace and a lot of that would come from Big Pharma,” Hanaman says.

But trials at large companies had suddenly come to a screeching halt.

“Big Pharma was suddenly working from home and if you weren’t doing COVID trials, but you were in clinical research, then you were sitting at home, and you were planning things for post-COVID,” Hanaman says.

Curavit pivoted quickly, focusing even more of its attention on small and midsize companies.

“Big Pharma has the luxury to be patient and that’s appropriate. Small, midsized biotech start-ups don’t,” he says. “They’ve got venture capital, they’ve got a binary equation on success. They’re either going to be successful or they’re not.”

Many early adopters of DCTs have historically been bigger companies, in large part because they have the resources to make the transition. But it’s actually smaller and midsize biotechs that stand to benefit disproportionately from decentralization, Hanaman says.

For these companies, DCTs have provided a lifeline to keep research moving.

An outsized benefit

For smaller pharma companies, DCTs can mitigate a number of challenges — from recruitment struggles to global deployment challenges. Decentralization can also help expedite trials, allowing them to adapt quickly in response to data.

Drugs and diagnostics at small to midsize companies typically target a focused, distinct audience, and often focus on rare diseases, Hanaman says.

“Decentralized trials allow them to recruit from all over the country or potentially all over the world,” Hanaman says.

Decentralized technology can also help facilitate global, multi-site trials, says Alison Holland, executive general manager, Digital and Decentralized Solutions for Medable, a software provider for decentralized trials.

“Very few companies, including the small to midsize, are working in just one jurisdiction,” Holland says. “They’re looking for broader exposure, broader registrations.”

According to Holland, decentralized trial providers can help to plan for site-specific needs, accommodating for local data collection, privacy, and regulatory requirements, which can vary by country.

DCT technologies and devices can also speed trials, allowing for more data collection in a shorter period of time, with greater efficiency and reach, Hanaman says. Researchers can then interpret this data more quickly and accurately, which can enhance patient safety, and encourage participation and participant satisfaction. For example, if a red flag is detected on a daily measure of blood pressure, heart rate, temperature or weight, the subject can be brought in for evaluation quickly.

DCTs also make trial participation more appealing because they require less hassle and travel to research sites. Easing the process helps to encourage those who might otherwise be reluctant to participate. This is particularly true for people who are in poor health, such as oncology patients.

“If home is a relaxing, safe environment for them, they might appreciate the option to be there,” Holland says.

Understanding the challenges

There are also some inherent challenges for small to midsize biotechs that chose to go the decentralized route. First, DCTs require an up-front investment, not only in terms of dollars, but of time, focus and energy, Hanaman explains. Making the leap ultimately enables these organizations to run more efficient trials going forward — but they have to get over that initial hurdle first.

Second, deviating from traditional research practices can bring risk and scrutiny.

“If everybody adopted DCT technologies and processes then everybody would start to benefit. But when one company does it, they expose themselves, correctly or incorrectly, to be challenged on their results,” Hanaman says.

For others, the main challenge is overcoming paralysis. Many companies are interested in DCTs, but simply don’t know where to start.

“It’s such an overwhelming thing,” Holland says, explaining that companies often don’t know how to adapt technology to their individual study.

For all of these reasons, many smaller organizations choose to dip a toe into the water rather than jump in all at once.

“A vast growing middle section of trials are hybrid, and that’s really where companies can and should be,” Hanaman says. “You don’t have to be all in on one or another. One can say, ‘What are the technologies that work for us? How do we design our trial from these digital first principles, and then add in traditional components in a way that is better for patients, better for research, better for outcomes?’ And that often is in this hybridized space.”

Strategies for successful implementation

In order for decentralization to work, it has to be implemented correctly. Some companies try to design a trial in a traditional way and then shoehorn in technology, Hanaman says. Instead of being more convenient for participants, the end result is a clunkier trial that increases the burden because participants still need to go to the site, but they also need to learn the technology.

Instead, companies should take a more comprehensive planning approach.

“I would encourage everyone to not to get overwhelmed by the breadth of what a DCT could be and to think about their protocol,” Holland says. “What’s the scientific question that their protocol is trying to answer?”

In particular, she advises that companies ask how they can answer that question in a more digital fashion, that allows for choices for the site and the patient.

Both Hanaman and Holland suggest consulting with DCT support providers as early as possible in the trial design process. This can help determine how technology can best be used to achieve trial aims. Ultimately, successful DCT adoption requires a focus on one core goal, Holland says.

“DCTs aren’t about no bricks and mortar, or no sites — it’s about amplifying the relationship between the site and the patient,” she says. “If we approach it from the perspective of ‘How do we engage patients with their clinicians and caregivers more?’ then it really opens up a huge opportunity for us to transform how we deliver healthcare and how we collect data.”

As the digital therapeutics/software as a medical device sector continues its significant growth, clinical trials for the products are projected to expand logarithmically.

The space is seeing a big transformation from merely following patient symptoms to serving as interventions in a growing number of areas, according to Mark Opler, chief resource officer for directing research and development at WCG MedAvante-Prophase.

“This used to be, I would say, almost a fringe category of potential treatments. It’s moved considerably from symptom tracking to intervention,” Opler told CenterWatch Weekly. “There is an ever-widening array of conditions and symptoms that digital therapeutics are intended to treat. Mood disorders, particularly depression, anxiety, those have been traditionally thought of as the core target categories for digital therapeutics, but as time goes by, we’re seeing applications to psychosis, to trauma and to other diseases, including attention deficit and related conditions.”

The FDA has already approved a number of digital therapeutics products. These include Akili Interactive’s EndeavorRx, an ADHD videogame treatment for children, NightWare’s self-titled product that uses an AppleWatch and iPhone to disrupt nightmares without disturbing sleep and a trio of Pear Therapeutics apps for chronic insomnia, opioid use disorder and substance use disorder.

Digital therapeutics can also be developed to serve as coaching tools to help improve certain behaviors. While some are intended to serve as standalone products, others are being developed for use in combination with drugs or other medical devices. The sector’s growth is predicted to grow to $12.1 billion by 2026.

Because patients are using a piece of software, not simply taking a drug, determining what will be used as the placebo can be a taller order. Some companies come up with “inactive,” nontherapeutic software to serve as the placebo, while others develop games or use treatment as usual for patients in the placebo control group.

But according to Opler, it may be more fruitful to concede that this method of blinding “may be on some level challenging, if not impossible” and go another route: using an evaluator that has as few ties as possible to the trial beyond assessing patient symptoms, an avenue for blinding that’s gained greater traction in digital therapeutics trials.

“What’s transpired instead when you want to evaluate efficacy in an objective way in a digital therapeutics study is to have a fully independent and blinded evaluator, someone who is blinded as much as possible to the treatment and the study design, and whose only contact with the patient is evaluating their symptoms,” Opler said. “It’s tough to find the sugar pill equivalent in a digital therapeutics trial. Blinding the evaluator, keeping them independent from other aspects of conduct of the study, is another route to ensuring that the evidence we gather is rigorous and will be acceptable to the larger community.”

Endpoints are another big issue for digital therapeutics trials, according to Dave Hanaman, president and chief commercial officer of Curavit, a virtual CRO…

BOSTON – January 5, 2022— Curavit Clinical Research announced today that it has taken all necessary steps to prove its good faith effort to achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA). Through the use of Compliancy Group’s proprietary HIPAA solution, The Guard™, Curavit can track its compliance program and has earned its Seal of Compliance™.

The Seal of Compliance is issued to organizations that have implemented an effective HIPAA compliance program using The Guard. HIPAA is made up of a set of regulatory standards governing the security, privacy, and integrity of sensitive healthcare data called protected health information (PHI). PHI is any individually identifiable healthcare-related information. If vendors who service healthcare clients come into contact with PHI in any way, those vendors must be HIPAA compliant.

Curavit has completed Compliancy Group’s Implementation Program, adhering to the necessary regulatory standards outlined in the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, Omnibus Rule, and HITECH.  Compliancy Group has verified Curavit’s good faith effort to achieve HIPAA compliance through The Guard. 

“HIPAA compliance is imperative for clinical research, increasingly so as the clinical trial model becomes more decentralized,” said Joel Morse, co-founder and CEO of Curavit. “As a virtual contract research organization that designs clinical trials from digital first principles, we take patient privacy very seriously, and have built our always–audit-ready platform on validated technologies that support our HIPPA compliant processes.”

According to a statement by Compliancy Group, “Clients and patients are becoming more aware of HIPAA compliance requirements and how the regulation protects their personal information. Forward-thinking providers like Curavit choose the Seal of Compliance to differentiate their services.”

About Curavit

Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs) from digital first principles. Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality and reducing patient burden. Curavit brings together the world’s leading researchers, enrolls previously underrepresented and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. For more information, visit www.curavitclinicalresearch.com.

Media Contact: Lisa Barbadora   (610) 420-3413   lbarbadora@barbadoraink.com

Innovation. Transformation. Change. Adapt. These words and all their synonyms were repeated ad nauseum during these past two years as people, companies, organizations, and industries were forced to make drastic changes in the face of a global pandemic. As Rajiv Sodhi, COO, Microsoft India, said, “Innovation is no longer an option, but a necessity.” That was in relation to a Microsoft-IDC study in which 77% of businesses in India said that innovation is now a “must” for them to respond quickly to market challenges and opportunities.

Of course, this isn’t an issue isolated to just one country or one industry. According to BCG’s April 2021 report, “Overcoming the Innovation Readiness Gap,”  75% of the 1,500 global executives surveyed across all industries said that innovation is top-three priority at their company—a 10 percentage point increase from 2020, which is the largest year-over-year increase in the 15 years of BCG’s Most Innovative Companies survey. Furthermore, more than 60% of companies plan to boost investment in innovation, with one-third of them planning to do so significantly.

If these companies stick to their word, we may be entering a new age of innovation. That may be a sight to behold because in our industry alone, the innovations over the past two years have been significant. Yes, that includes COVID-19 vaccines developed in record time, but it’s more than that. Healthcare delivery, clinical trials, commercialization efforts, organization management, and much more were all reimagined to work better during a pandemic and even well into the future as we embrace our next normal.

For the past decade, our annual Innovations Issue has served as your guide to all things new and next in the industry to better prepare you for the future. As innovation only grows more crucial, so does this guide. From hundreds of submissions, we picked the most gamechanging innovations you need to know about in the following categories:

• Companies (any organization developing new ways to push the industry forward)
• Divisions (new sectors formed to address a particular problem facing the industry)
• Startups (companies less than five years old pioneering new avenues in healthcare)
• Products (software, apps, programs, and anything else designed to improve how those working in the industry do their jobs)
• Services (compelling offerings that help the industry tackle new challenges)
• Strategies (never-before-tried approaches that are changing how the industry operates)

These selections are meant to aide in your own innovation journey with potential partners, worthwhile offerings, and inspiring ideas that can help you stay ahead of the game in a world that has now made innovation one of its top priorities.

Listen to full podcast here

NEXT FRONTIER: The next frontier for clinical trials is in-silica research, also – confusingly – called virtual trials. In this future of research, “subjects” are computer models, data is real world data (RWD), and the experiments are conducted through computation – not human observation and measurement. There are already some good examples of this. The Economist recently reported on the one from the UK, but it will be a very long time before this is a significant disrupted to clinical research.

Curavit Clinical Research announced the appointments of Jay Collier, as Chief Operating Officer, and Candice Del Rio, as Director of Clinical Operations.

Before the pandemic, a December 2019 Industry Standard Research survey found that 38% of pharmaceutical sponsors and contract research organizations (CROs) expected virtual trials to be a major component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. One year later when attendees at McKinsey’s Clinical Operations Roundtable were asked the same questions, the responses were 100% and 89%, respectively.

Today, most are asking what trials and what aspects of trials can be effectively decentralized and to what degree. Fully virtual or decentralized clinical trials (DCTs) typically handle all enrollment processes and assessments in a patient’s home, enabled by end-to-end digital tools and involve the self-administration of medicines. This model is gradually migrating from smaller, early-phase and post-approval studies toward larger pivotal trials, such as Otsuka and Click Therapeutics’ landmark fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing symptoms in adults diagnosed with major depressive disorder (announced in Feb 2021).

In the near term, sponsors, investigators, and CROs expect fully virtual trials to remain limited to a narrow set of use cases, such as a well-characterized drug with few adverse events in a mild indication, with end points suited to remote measurement. Long-term, however, fully virtual trials will be more widespread—especially in certain therapeutic areas such as rare disease, mental health, central nervous system, neurodegenerative and others that require patient populations that can’t physically travel or don’t live near a site.

Ultimately, the therapeutic area alone shouldn’t determine a trial design. Rather, each trial should be designed for-purpose and centered on patients. The target patient population, treatment, and indication will primarily determine whether a trial is fully virtual, hybrid or a traditional site-based trial. Even so, there are defining patient population characteristics in many therapeutic areas that can make some studies more likely candidates for all-virtual research.

Here are five therapeutic areas that are particularly apt for an all-virtual research approach, and that can serve as an entry point for hesitant sponsors interested in exploring this growing DCT model.

Diabetes—More than one in 10 Americans have diabetes and one in three or 88 million adults are prediabetic. Given the disease’s prevalence and its widespread geographic reach including many rural areas, diabetes is ripe for fully virtual research. Blood glucose values can be monitored continuously with wearable devices attached to the patient’s skin and automatically uploaded to a central platform in the cloud for easy access by trial investigators, sponsors, and the patients themselves.

In addition, the propensity of patients with Type two diabetes to be elderly or struggle with obesity can make it difficult for patients to travel to trial sites. These patients often have vascular problems which also can also hinder mobility. Further, diabetes is rampant in certain demographics such as Native Americans who are twice as likely to have diabetes as whites and often live in remote rural areas far away from the nearest clinician. Virtual trials bring lifesaving treatment to these patients and further the development of treatments that reflect the unique needs of a more representative population.

Cardiovascular—With wearable devices, including Apple watches, that monitor increasingly more sophisticated and wider range of cardiovascular endpoints remotely, research focused on cardiovascular diseases are apt for a fully virtual trial design. These devices accurately monitor and measure cardiac events and catch issues, such as atrial fibrillation (a common type of sustained cardiac arrhythmia) and ventricular tachycardia (abnormally fast heart rate) to alert the patient and remote physician in real time. Even some clothing items, such as bras, have sewn-in heart monitors! There are other devices that can be worn continuously for months at a time to capture more sophisticated measurements and automatically send data into the cloud. The same is true when it comes to managing blood pressure.

Like diabetes, cardiac patients are in all corners of the world and often many hours from central research sites and—due to their condition—may have mobility challenges and concerns. Virtual trials extend access to the millions living with heart disease and high blood pressure. Further, the data gained from continuous and multiple-symptom monitoring of cardiac patients is dramatically more useful in comparison to the less-reliable, one-hour, single-symptom testing completed at a site once a month or every few months. Heart arrhythmia often occurs only intermittently so it may not be picked up at the occasional site visit. Today’s wearable devices monitor blood pressure, heart rate and rhythm, and oxygen saturation levels as well as activity level (steps taken) so researchers can superimpose different measurements depending on what endpoint is being studied or combine multiple measurements for more meaningful information.

Central nervous system (CNS) diseases—Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s disease, and other CNS diseases may dramatically impact patients’ mobility as well as hamper caregivers’ ability to bring affected loved ones to frequent clinician visits. All-virtual trials open these patients up to potential opportunities they might not otherwise ever have for a treatment.

Like cardiac wearable devices, there are an increasing number of new technologies that allow researchers to measure novel endpoints of patients in the comfort of their own homes and in more realistic life settings outside of a doctor’s office. Devices can continuously measure number of hand tremors per minute, for example, so a novel endpoint could be the reduction of hand tremors which was not as easily studied in traditional trials.

An electroencephalogram (EEG) is a widely used non-invasive method for monitoring the brain but has historically been a large and bulky technology, restricted to the monitoring of subjects in a lab or clinic while they are stationary. Today, we can use a wearable EEG, which overcomes these limitations and allows the long-term, non-invasive recording of brain signals at home.

Neuromuscular trials—Like patients with CNS disorders, patients struggling with neuromuscular diseases, including Duchene Muscular Dystrophy may have severe mobility challenges that make it difficult to make regular clinician visits. Fortunately, there are advanced activity monitors that do not interfere with movement on these patients such as ankle bracelets that can record various measurements continuously to, say, show how much activity a person takes part in over a period. Red Nucleus Clinical’s iTakeControl platform is a clinically approved solution that enables HIPAA-compliant video assessments of patients, live video research visits and audio recording to provide richer audio/visual data that is also auditable for compliance purposes.

Decentralized Clinical Trials (DCTs) have taken the main stage in the clinical trials industry, which was significantly facilitated during the pandemic. However, similar to the initiation of risk-based monitoring (RBM), the concept of DCTs is at an infancy stage, and many enterprises are competing to make their mark in the field. This prompted the formation of the Decentralized Trials & Research Alliance (DTRA) to help better define and advance DCTs. In this article, Dave Hanaman, Co-founder of Curavit, will discuss his perspectives on DCTs.

Moe Alsumidaie: What is a Virtual CRO (VCRO)?

Dave Hanaman: Co-founder Joel Morse and I conceived the company from our experience at C3i, where we spent 20 years at the intersection of digital technologies and clinical research. We saw this space evolving for years and wanted to disrupt research by positively applying technology in new ways. So we launched Curavit officially in November 2019 and became the first virtual CRO—a contract research organization dedicated exclusively to designing and executing decentralized clinical trials.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

As a VCRO, Curavit runs fully decentralized trials from start to finish and acts as a virtual site, managing the decentralized components of a hybrid clinical trial. We leverage industry-leading digital technologies, devices, and our cloud-based DCT platform to centrally capture, aggregate, manage, and analyze trial data for sponsors. Curavit also brings specialized therapeutic expertise for decentralized trials to ensure the most proficient minds and the best technologies are applied to every research study.

DH: Yes, and the technology is catching up to the vision. In 2007, Veeva introduced cloud-based CRM to an industry desperate for lower-cost technology models because so many major brand-name blockbuster drugs were coming off patent. Veeva’s well-touted success is an example of the right solution at the right time. Decentralized trials are similarly destined, supported by developments in IoT, wearables, and big data. People have been working to make DCT a reality for years, but the technology is finally maturing and readily available while the industry is calling for a greater focus on patients and access to trials for all. So once again, we have a case of the right solution at the right time.

MA: Are there concerns around data privacy and what precautions is Curavit taking to protect it, especially now where the U.S. and many Western nations are under attack by foreign hackers. What can be done to address those concerns using a DCT model for research?

DH: From banking to life sciences, every industry is extremely concerned about protecting data. As in most things, there are tradeoffs. Decentralized trials that do not involve sites can be an advantage in limiting data risk. DCTs can be much more secure in many ways because you can centralize data in very safe, modern cloud systems. That is what Curavit is doing.

Curavit’s platform has been purpose-built for decentralized trials with proven, industry-leading software. HIPAA compliance and validation are built into the individual tools as well as the overall platform. No corners were cut in terms of applying modern cyber defenses.

MA: Part of Curavit’s vision is to make research more accessible across all the demographics. How are you expanding clinical trials to those demographics through DCTs?

DH: First, DCT technologies and processes are fundamentally more suited to reaching previously underserved or underrepresented patient populations. It’s easier to expose more people to the opportunity to participate in research across social media, digital communities, and websites supporting specific diseases or conditions.

Second, and more specifically, DCTs leverage community-based outreach. For example, we partner with Clinispan out of North Carolina whose purpose is to recruit underserved populations. Par 80 in Boston partners with community health centers serving minority populations. These efforts reach out to minority populations to include those who distrust or have not been previously exposed to research.

Third, we have had ongoing discussions with a global pharmaceutical company interested in Native American populations that embody two distinct underserved groups: indigenous and rural populations.

MA: Where do you see DCTs going in the next ten years?

DH: Optimistically, in 10 years, we won’t think of DCTs as unusual because the technologies and processes will be commonplace. DCTs won’t be any more novel than computerized businesses are today.

Most data capture will be in the cloud a decade from now, and DCTs will enable a more burdenless patient research experience. To clarify, that doesn’t mean face-to-face interactions with physicians will go away. Even in complex therapeutic areas like oncology, there’s plenty of opportunities to use digital technologies to gather new data and reduce patient burden. We won’t think of DCTs as a distinct subset. In 2031, DCTs will have disrupted clinical research in profound ways that are better for all patients, better for all sponsors, and ultimately better for public health.

An understanding of human nature suggests that in a post-COVID-19 era for clinical trials, the pendulum may temporarily swing away from the increased adoption of decentralized clinical trials (DCTs) and hybrid approaches that we’ve been witnessing and revert to something more closely resembling the traditional, in-person trial conduct practitioners and patients had been used to before 2020. However, Dave Hanaman, chief commercial officer for Curavait Clinical Research, sees “steep continued growth” in the years to come for new technologies and approaches that he believes can significantly advance the quality and reach of clinical trials.

“DCTs present a new opportunity to meet patients wherever they are,” says Hanaman. The approach they offer represents “an effective way to bring the trial to the patients,” he adds.

Acknowledging some industry “growing pains” as hybrid trials and DCTs have begun to take hold, Hanaman warns that some hybrid approaches are “the worst of both worlds,” with too heavy a physical footprint and overuse of technology.

However, Hanaman sees “strong levels of adoption” for hybrid trials in the next five to 10 years. “Much of the resistance has dropped,” he explains. “I think their use will be taken for granted” in the years to come, he says.

Hanaman is excited, too, about how hybrid trials and DCTs can expand the reach of clinical trials. In addition to traditionally underserved patient populations like African Americans and Hispanics, Hanaman notes the new technology and approach could improve trial access for native American and rural white populations. “Native American populations are often very far away from physical research sites,” he notes.

Further, internet coverage, long an obstacle to increased use of telehealth and DCTs, has improved in many of even the most geographically remote parts of the United States, Hanaman says.

DCTs and hybrid trials represent “a tremendous opportunity for patients and science,” he says. “I see so much more enthusiasm for [such approaches] to be included in trial design, and [they] will help us better reach the patients we’ve been missing.”

Curavit Clinical Research, a virtual contract research organization (VCRO) that designs and executes decentralized clinical trials (DCTs), announced today that it has joined the Decentralized Trials & Research Alliance (DTRA) to further the advancement and adoption of decentralized clinicals. Curavit Clinical Research has also announced the appointments of Jay Collier, as chief operating officer (COO), and Candice Del Rio, as director of clinical operations. The company also expanded its sales team with the hiring of Chris O’Shaughnessy, as vice president of business development, as well as Troy Hall and Bill Dreyer, as directors of business development. The expansion comes as DCTs continue their steady growth, punctuated by Curavit’s doubling its revenue since 2020.

Curavit has joined the Decentralized Trials & Research Alliance, an industry-backed non-profit organization focused on the promotion of remote studies.

Membership of the group will see Curavit take part in the development of the fast growing the decentralized clinical trials market according to co-founder, president and chief commercial officer, Dave Hanaman.

“DTRA provides a broader platform for Curavit to discuss the innovations and research improvements that we are driving for our clients. Curavit will also have the benefit of collaborating with other innovators to solve new or emerging challenges in a way that is meaningful for the entire industry.”

Demand for decentralized trials has increased significantly in recent years – particularly since the pandemic – Hanaman told Clinical insider and predicted demand would continue.

“Curavit sees demand for DCTs daily in the form of customer feedback. Clients are developing long-term plans to leverage decentralized components in most of their trials. COVID-19 changed the industry’s approach, impacting everything from long-range planning to execution and it doesn’t seem like we are going back to traditional methods.”

He added, “Today, most trial designs have at least on decentralized component included and every large pharmaceutical company Curavit has spoken to over the last year has established a DCT group or team – often referenced as innovation team, trial optimization group, digital team or other similar nomenclature denoting DCTs.”

Curavit was established in 2020 in a bid to tap this growing section of the market. Last month the CRO expanded its sales team in a bid to broaden its service.

Hanaman said, “Curavit is a new company and establishing its sales force from scratch, so we need team members to support the demand. Prior, just Curavit founders have been managing client inquiries and working with clients to ensure long-term satisfaction and responsiveness.

“With our growth, that is not sustainable, as the Curavit leadership also need to devote time to helping to develop unique therapeutic-area-specific solutions for our clients.”

Image: Stock Photo Secrets

Beech Tree Labs has developed a novel drug development platform known as resonant molecular signaling (RMS), that aims to address a wide range of illnesses by restoring normal cellular communications and correcting various imbalances triggering problems. The company opted to go virtual for their next Phase 2, FDA-authorized clinical trial to evaluate the effect of Beech Tree’s BT-TML therapy targeting COVID-19 patients. Although many companies have moved to at least some provisional virtual or hybrid approach during the pandemic, Beech Tree Labs took another step toward a permanent move to virtual trials by partnering with Curavit Clinical Research for a fully decentralized trial. The Park City, Utah-based venture has an ambitious plan to disrupt the operation of clinical trials, accelerating timelines and reducing cost while maintaining if not improving quality with improved, patient-centric care.

Move to Decentralized or Virtual Trials more than ‘Flipping a Switch’

Recently, TrialSite writer Joseph Constance assessed the emerging virtual clinical trials landscape particularly in the midst of the COVID-19 pandemic. In an earlier piece, Constance suggested the move to decent…

A Chapel Hill startup that helped bring diversity to Novavax’s (Nasdaq: NVAX) clinical trials for its Covid-19 vaccine is in the process of raising $250,000 in funding to help it continue to grow.

CliniSpan Health is actively raising seed funding to grow its team of eight to 20 by 2022, said Dezbee McDaniel, the company’s co-founder and head of business development who earned his undergraduate degree from UNC-Chapel Hill.

“We are looking to grow rapidly,” McDaniel said.

The company was started with the goal to bring more diversity to clinical trials, and in January the Novavax trial was the first CliniSpan began recruiting for, McDaniel said. About 17 percent of the Black participants at the Durham clinical trial site and 20 percent at the Chapel Hill site were referred to Novavax by CliniSpan, McDaniel said.

The lack of diversity in clinical trials has been an ongoing problem for years.

In 2020, the U.S. Food and Drug Administration approved 53 novel drugs that had clinical trials with a total of 32,000 patients. Of those patients, 75 percent were white, 8 percent were Black, 6 percent were Asian and 11 percent were Hispanic.

“We are heavily focused on African Americans right now,” McDaniel said. “We want to expand to groups who are Latinx, Native American, rural, women – a lot of other diverse groups who also need access to clinical trials.”

For now, the company is focusing on one population at a time, McDaniel said, because each group has a different history with the medical system and different preferences for how they want to be communicated with.

“With African Americans, the past mistreatment by the health care system is what we have to overcome and that’s something we haven’t directly affected, so it’s difficult to have that conversation sometimes,” McDaniel said.

Having people who reflect those groups do the outreach and recruitment helps make people more comfortable in participating, he said.

The transition to more decentralized trials also helps, McDaniel said.

“If people don’t have to show up physically and they can do it from home, then access for us becomes that much easier of a goal to achieve,” he said.

In addition to the Novavax trial, CliniSpan has partnered with Curavit, a fully virtual clinical trial organization, which perfectly complements CliniSpan’s infrastructure, McDaniel said.

CliniSpan has also signed a licensing agreement for its software with Capstone Health Alliance, a group purchasing organization for hospitals, he said.

“That’s something we’re trying to grow outside of our recruitment services,” McDaniel said. “We’re trying to help other diversity recruitment arms have technological infrastructure to carry out their processes more effectively.”

At the same time, CliniSpan will be helping to recruit for studies that its hospital network participates in, McDaniel said.

CliniSpan, which is led by founder and CEO Dr. David Lipsitz who did his residency at UNC-Chapel Hill, is currently working with five businesses in total and is generating revenue, though McDaniel did not disclose how much.

Virtual clinical trial providers are your must-partners for any decentralized trial or contingency plan. In March 2020 the FDA encouraged sponsors to assess alternative methods for keeping their trials on track within the existing limitations under Covid-19 quarantine. Remote/virtual trials are no longer just a convenient way to shorten timelines and reduce costs but a rescue solution to ongoing clinical trials. From recruiting participants to designing their virtual experience, remote trial providers and technology can save your data and your budget.

A new clinical trials company, Curavit Clinical Research, has been launched to help realise the potential of decentralised clinical trials.

Launched by industry veterans Joel Morse and Dave Hanaman, the new entity will focus on virtual trials.

Curavit Clinical Research co-founder and CEO Joel Morse said: “Curavit is the result of our desire to solve growing challenges to the important work of drug discovery.

“By combining experience, technology, and solid execution, we will bring cutting-edge research to previously untapped and underserved patient populations.”

Curavit Clinical Research is a next-generation clinical trial enterprise that provides decentralised clinical trial execution. It takes a clean-sheet approach to clinical trials, from the design phase to execution.

Optimised on a new virtual model, the company supports patients’ participation from wherever they live.

Curavit Clinical Research chief commercial officer and co-founder Dave Hanaman added: “We are fortunate to have worked with some of the most respected companies and visionary people in the life sciences industry, and are honored by the support we are receiving from them for this effort.”

Global clinical trials market stands at $70bn and continues to grow, while the success rate of trials continues to see a decline. This is often due to lack of enrollment by patients and participation from doctors.