The Future of Decentralised Clinical Trials

COVID-19 has driven innovation in clinical trials, but what happens next and how can pharma prepare?

Pre-pandemic many companies were curious to explore the potential of decentralized clinical trials (DCTs), but now see this approach as a necessity for recruiting and retaining patients while minimizing physical contact. The advantages are many: faster results, shorter time to market, reduced overheads and reduced on-site burden. While DCTs may never replace traditional clinical trial practice it has the potential to radically streamline the process. Many industry thinkers believe decentralized studies may become the 'new normal,' raising the question: what changes must pharma make to smoothly transition to the DCT model and what challenges must it overcome?

To help you understand the drivers and limiters of a DCT future we interviewed, in The Future of Decentralised Clinical Trials, knowledgeable experts to give you a clear perspective of the current environment and future development pathways this rapidly emerging field could take.

Experts explore decentralized clinical trials

• What factors/issues in patient experience should researchers consider in DCTs?
• Setting meaningful clinical endpoints for DCTs is critical—what does pharma need to take into account?
• How will companies overcome data ownership, privacy and security challenges?
• What advantages will pharma get from the effective use of continuous patient data?
• In what ways can pharma use predictive analytics/modelling to increase the likelihood of DCT study success?
• How might the regulatory landscape change post-COVID-19 and what will it look like in the next 5-10 years with respect to DCTs?

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What are Decentralized Clinical Trials?

The term 'decentralized clinical trial' has often been used interchangeably with virtual, remote and hybrid trials. While definitions vary, the key difference between approaches is that while 'virtualized' can refer to trials that are conducted without human participants, in silico, or to trials that require no site visits, 'decentralized' is more inclusive and can refer to fully remote studies or hybrid studies that use a blend of technology and traditional trial methods.

Read Virtual Medical Conferences: The new normal? to hear from leaders in the field about their virtual conference experiences over the last few months of the pandemic as well as their thoughts on what the future holds for the medical events sector.

What our experts say…

"Virtual meetings have expanded the global reach: Virtual meetings broadens accessibility, enabling people that would otherwise have not been able to participate, to take part. In addition, it also widens accessibility in terms of conference content through having information available on-demand. This way, knowledge can be harnessed from any location at one time and be shared with a wider audience."
R'Kes Starling
CEO Reveles Clinical Services

"The rate-limiter for DCTs tend to be the availability of robust endpoints that can be captured at a decentralized site. The slow but steady adoption of digital endpoints will be the catalyst for more studies to embrace DCTs and decentralized research methods. Out-dated and fragile endpoints that require patients to visit a site to avoid any semblance of noise will remain a barrier to adoption; sponsors must embed time into their development plan to evaluate and invest in novel digital endpoints."
Craig Lipset
Founder of Clinical Innovation Partners

"The regulatory landscape is already changing to support decentralized study approaches such as eConsent, eCOA, sensors, telehealth, and device-reported outcomes. As these solutions become more of the standard, regulators are expected to detail these solutions by name within updated regulations so that these solutions are less 'grey' in their descriptions of use and context in clinical trials. Many in our industry (including me) believe that hybrid decentralized studies will become the norm with regulators in the next 5–10 years."
John Reites
President of THREAD

Case Studies

• How the FDA is facilitating DCTs during the COVID-19 pandemic
How Alexa is expected to enhance the patient experience of DCTs

What to expect

• A detailed report which explores the emerging use of decentralized clinical trials, the practical advantages they provide and the regulatory, operational and patient challenges that must be overcome
• An examination of 9 key issues which pharma and CROs need to understand and respond to
• 17 targeted questions put to experts
• •
• Their perceptive responses that provided 44 insights supported by 42 directly quoted comments

Expert contributors

Contributors to this report were carefully selected and screened to ensure they:

• Are a manager or executive who has been involved in planning or conducting DCTs
• Had at least 3 years' experience in the field of pharma R&D
• Had direct experience in creating or implementing solutions or strategies for DCTs in the last 24 months

Contributors to the report

• Craig Lipset is a clinical trial expert, serving as an advisor and member of the Board of Directors for several technology and biopharmaceutical companies. His focus is on developing the intersection between research, digital solutions and patient engagement. For this report, Craig leverages his clinical trial experience, which includes eight years as the Head of Clinical Innovation at Pfizer. Craig also designed and launched the first fully remote virtual clinical trial for a new drug, among other innovations. He has been recognized for his achievements by reputable life science publications and is currently an Adjunct Assistant Professor in Health Informatics at Rutgers University.
• R'Kes Starling is the Chief Executive Officer at Reveles Clinical Services. He is responsible for Pharmacy and Clinical Research Operations Management, with a focus on decentralized clinical trials. His expertise in this field encompasses hybrid/virtual clinical trials, clinical development Phases I-IV and policy and procedure development, among others. R'Kes also has over 15 years of experience in core competencies such as operations, regulatory compliance, sales, customer retention strategy and pharma distribution markets. His patient-centric approach has resulted in consistently high performances in his clinical trial operations.
• John Reites is the President of THREAD, a unified global platform designed for Sponsors and CROs that decentralizes and automates how clinical research is conducted to make studies more efficient, comprehensive and inclusive. With over 18 years of experience in digital health and global drug development, John has strived to simplify clinical trials through decentralization and advance remote data capture from participants and sites during, in between and in lieu of in-clinic visits. John is a frequent keynote speaker at top tier industry events and serves as a guest lecturer on digital health, clinical research innovation and entrepreneurship at Duke University in the U.S.

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FirstWord's FutureViews reports analyze in detail significant emerging technology and market trends that industry executives need to understand if they are to manage the opportunities and challenges that lay ahead. These concise and highly focussed reports:

• Are based on primary research with experts whose knowledge and current experience is proven
• Present clear expert insights free from secondary source information and spurious observations
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