Woodcock: Network of Trials in Community Practices Would Yield Better Results
The clinical trials industry’s experience with COVID-19 makes one thing very apparent, says Acting FDA Commissioner Janet Woodcock: the current decentralized structure of trials around the world hampers researchers’ ability to get out in front of the virus.
The current clinical trials ecosystem allows too many duplicative and underpowered trials, Woodcock said, and creates more competition than collaboration. “What we saw with the pandemic was simply the expected outcome of the system that we have.”
It’s time to make some changes, Woodcock told attendees of a National Academies of Sciences, Engineering and Medicine (NASEM) workshop last week, and learn from today’s failures to prepare for future crises.
Woodcock, considered in many circles to be the frontrunner for leading the FDA in an official capacity, suggested that stakeholders build and the federal government support a community-based trial network to be better prepared for the next pandemic. “Community sites, we learned during this pandemic, can be supported by specialized CROs or other organizations that supply the education and expertise to enable clinical research,” she said. “Central IRBs and simplified data that can be collected from [electronic health records] are now ubiquitous and can lower the procedural and monetary costs.”
The concentration of research at academic medical centers creates needless competition for the same pool of trial participants, she said. “Meanwhile, vast numbers of people with disease are cared for in other settings and have no opportunity to participate in clinical research. And so not only is research slowed and we don’t generate the evidence that we need, but those people and practitioners have lost out on the chance to participate, contribute and maybe even benefit from the research that’s being done.”
In the interim, she said the new network should “practice and generate actionable evidence on important questions in the care of people with chronic diseases.”
The NASEM workshop presented an overview of topics that will be addressed in three future meetings on the future of the clinical trials enterprise by 2030: patient-centered and inclusive trials, building resilient, sustainable and transparent clinical trials, and using new technologies.
Future workshops will be held on Feb. 9, March 24 and May 11.
To view a webcast of the first session and register for future sessions, click here: https://bit.ly/2MaAlHe.