FDA Not Ready for Innovation Guidance Yet, Acting Commissioner Says
Decentralized clinical trials are here to stay, but the FDA won’t be ready to move forward with more formal recommendations until the pandemic is over, according to Acting Commissioner Janet Woodcock.
Woodcock said many innovations, such as telehealth, were in the early stages of adoption in the clinical trials industry when the pandemic hit. Since then, “everyone has discovered, ‘Gee, it works a lot better than we were worried about.’ So, I think remote clinical trials is something that would be here to stay,” she told attendees of a presentation last week sponsored by the Alliance for a Stronger FDA.
But Woodcock added that two recommendations from the FDA’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative — specifically, to clarify plans for existing guidance and publication timing for forthcoming guidances, and to use the experience of the pandemic as a catalyst to defining a broader, agencywide approach to encouraging sustained innovation in clinical trials — would probably have to wait for now. Other innovations on the cusp of greater use are adaptive trials, master protocols and real-world evidence, she added.
“We’re still in the middle of the pandemic and we have to recover, so we will obviously be incorporating some of those things as we go,” Woodcock said. “But some of them will require more broad public input and discussion before we make them an instantiated practice going forward.”
Read the PREPP report here: https://bit.ly/3dXMR6E.