BIO 2020: Are We Ready for Decentralized Clinical Trials?

Wade Ackerman is quoted in BioSpace regarding the decentralization of clinical trials in the pharmaceutical industry. Mr. Ackerman says the “all hands on deck” approach to the pandemic by Congress and the FDA set the stage for clinical trial innovation. “It has set up a lot of conversations about where telehealth is, and where it will be six months from now,” he adds. “When the new Congress convenes in January, it will have an 18-month runway to the next FDA user fee authorization, so there will be significant policy discussion on the Hill about these issues.”

With pharma sponsors looking for greater guidance on decentralized trials, “There’s an inertia in the FDA and in the industry. There’s already a tried and true pathway for clinical trials, so does any sponsor want to take risks (by using decentralized trials)?,” he adds.

Mr. Ackerman says, “Because of a public health crisis, the industry has pushed to adopt technology that otherwise would have been adopted in a step-wise approach. The promise is there, but there are cautions, too. There are a lot of layers to work through, and a lot of thought must be given to each step. I encourage people to collaborate with the FDA in evolving areas. Keep a positive mindset and be engaged as you hit the gray areas.”