Several of the world’s healthcare, bioscience and pharmaceutical firms, including such global leaders as AstraZeneca, Pfizer and Biogen have joined together to accelerate the adoption of decentralized clinical trials and research.
In the planning stage before the coronavirus pandemic, the Decentralized Trials & Research Alliance (DTRA) formally announced its founding this month. With an initial membership of some 50 organizations, the alliance declared its mission to “make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.”
Explained Amir Kalali, MD, co-convenor of DTRA, “The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate.
“The COVID-19 pandemic has forced organizations to adopt decentralized methodologies which have the potential to broadly accelerate drug development.”
Decentralized trials, also (imprecisely) referred to as virtual trials, allow patients to participate without the need to regularly or ever visit a research site. Through telemedicine visits, remote monitoring, wearables and smartphones, researchers can often collect as much or more data in many cases, and often more reliable data, than by requiring in-person visits.
Several months ago we blogged about the increasing use of decentralized trials – those that are entirely remote and those that include occasional face-to-face visits. In that June post we noted that “prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.”
Speaking at the virtual BIO 2020 conference, panelists agreed that the foothold COVID gave to decentralized trials will continue to grow, in large part because of its patient benefits. With participants freed from having to travel to research sites, it opens opportunities to recruit underrepresented populations. One example, cited by a panelist, was the potential now to include autistic patients.
DTRA, in its founding announcement, said, “Inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators.”
Added Craig Lipset, DTRA co-convener, “Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives.”
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