The Power of Decentralized Clinical Trials | A Medidata NEXT Global Series
Medidata’s annual event series—NEXT Global—brought together leaders from across the life sciences industry, including representatives from Parexel, Moderna, and more, to explore the prominent role of decentralized clinical trials (DCTs) in modern clinical research.
We’ve compiled highlights of these discussions below, including the importance of DCTs in regards to clinical trial diversity at Parexel, as well as the pivotal role of decentralizing technologies in Moderna’s highly-successful COVID vaccine trial.
All Things Decentralized Clinical Trials with Parexel
In this session, Medidata Patient Cloud CEO, Anthony Costello, sat down with Parexel’s Rosamund Round, VP, Patient Innovation Center and Decentralized Trials, in a wide-ranging discussion around DCTs and inclusivity in clinical trials.
A decentralized trial, at its core, provides the opportunity for patients to participate in research without visiting a traditional clinical research site. The range of decentralization will vary by trial, but adding decentralizing elements into a protocol—even small adjustments, such as ePRO studies, eConsent at home, or video visits—can have a large impact on reducing patient burden.
By working with sponsors and sites to design decentralized clinical trial frameworks from the first visit to the end of the trial—including post-trial follow-up—we can gain a fuller view of the patient experience while expanding opportunities for trial participation. Tools like micro-sampling (which lets patients conduct blood draws themselves) and sensors (which allow for continuous monitoring, as opposed to a few minutes or hours on-site) are just a few decentralizing solutions being explored by Parexel. Such tools can help expand the accessibility of clinical trials to more patients.
Diversity and Decentralized Trials
Among Parexel’s key initiatives is improving outreach to diverse and underrepresented patient populations in clinical trials. DCTs can be a critical part of this strategy. Members of minority racial and ethnic groups, as well as the transgender and non-binary communities, have long been neglected in clinical research. These groups have also expressed hesitance and fear of feeling comfortable in a medical setting or clinic. Key concerns, such as “will people be respectful of me?” must be understood and considered when promoting clinical trial inclusion.
Decentralized clinical trials can reduce the financial, practical, and geographical burdens of participation for these patient populations. DCTs offer support for patients who would rather participate from home or may need to participate remotely due to schedules or life circumstances. Greater access to trials by implementing decentralized elements, combined with improved community outreach and awareness, can have a marked contribution on clinical trial diversity in the future.
“The last few years have shown us that focusing on supporting underrepresented communities in learning about and participating in research is absolutely critical. DCTs aren't the only answer, but if done well, they can definitely have a positive contribution to moving this area forward.”
– Rosamund Round, VP, Patient Innovation Center and Decentralized Trials, Parexel
Solving the Impossible for COVID-19 with Moderna
In this session, Medidata’s Jackie Kent and Jason Dacko sat down with Laurie Callen, Senior Director of Clinical Data Management at Moderna to explore how technology and decentralized trials brought Moderna’s highly-successful COVID vaccine to market.
Moderna brought their COVID-19 vaccine through the full clinical trial lifecycle in under one year—enrolling 30,000 subjects in just 12 weeks. Such a feat required robust clinical trial solutions from a technology perspective. Moderna incorporated numerous decentralization capabilities to deliver their large-scale trial in extraordinary time.
The Medidata-Moderna Partnership
The Medidata and Moderna teams worked closely together to assess the various solutions available, including decentralized trial technology and tokenization, to determine which tools would best support the trial. Moderna used a suite of Medidata tools, including Medidata Rave EDC (electronic data capture), Medidata eCOA (electronic clinical outcomes assessment), and Medidata Detect (centralized statistical monitoring) to improve data integrity and reduce trial risk without affecting trial quality and timing.
The innovations and clinical trial technologies that drove success in Moderna’s COVID vaccine trial will influence how future trials are conducted. Identifying which decentralizing solutions and clinical data management tools were most beneficial will help Moderna continue to deliver high-quality medicines and therapeutics for patients worldwide.
“The Medidata team truly was—and still is—very much an extension of Moderna. Each Medidata team member was called to action and supported this very important trial and showed dedication and commitment to a greater cause.”
– Laurie Callen, Senior Director, Clinical Data Management, Moderna
Decentralized trials not only offer multiple ways to engage and monitor patients, but also new opportunities to collect data to better inform decision makers. The accessibility, convenience, and flexibility of DCTs help patients make time to participate in research and attend their scheduled appointments. Decentralized clinical trials can also drive efforts to expand clinical research to underserved patient populations. As patients, we are now beginning to expect decentralization methods when receiving care or participating in clinical trials—a trend that will undoubtedly continue as DCTs evolve further in the clinical trial space.
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