The U.S. Food and Drug Administration (FDA) announced April 28 that it is advancing real-time clinical trials (RTCT) to accelerate the testing and development of drugs, citing two proof-of-concept clinical trials and a proposed pilot program for RTCT.
FDA Commissioner Marty Makary stated in a press release that clinical trials, as typically conducted, often result in data from the trial sites taking years to reach the FDA.
“The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline,” he said. “We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses. This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.”
According to the release, the FDA has already initiated two RTCTs conducted by AstraZeneca and Amgen on treatment-naïve mantle cell lymphoma and limited-stage small cell lung carcinoma.The FDA said it worked with both trial sponsors to set up real-time signal reporting and has successfully received signals, demonstrating “the feasibility of the technical framework” needed to continue RTCTs.
The FDA also released a Request for Information on a proposed RTCT pilot program that would build on the already conducted RTCT trials and be launched this summer. The request asks for input on the program’s design, implementation, and metrics for evaluation and success, according to the release.
Chief AI Officer Jeremy Walsh stated in the release that the initiatives have demonstrated that RTCTs are “not only possible, but also potentially transformative for the clinical trials ecosystem.”
“We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment,” he said.
The initiatives to speed up clinical trials come amid the Trump Administration’s move to accelerate research into using psychedelic drugs for treating serious mental illnesses, as Zeale News previously reported.