FDA announces real-time clinical trials, request for information

The Food and Drug Administration April 28 announced its plan to advance the implementation of real-time clinical trials, which invite participants to supply reports and data to the agency during the approved clinical trials rather than at completion. The agency said it had already completed two proof-of-concept trials using RTCT reporting. As part of the announcement, the FDA issued a request for information on a proposed pilot program to assess AI’s impact on efficiency, speed and quality of decision-making in early phase clinical trials. The agency will accept comments, submitted through regulations.gov, for 30 days following publication in the Federal Register.