FDA Says First 'Real-Time' Clinical Trial Is Underway

FDA Says First 'Real-Time' Clinical Trial Is Underway

(MedPage Today) -- The FDA announced the launch of the first "real-time" clinical trial, with a second soon following, that will enable agency reviewers to see certain data signals immediately. Both are cancer trials and considered proof-of-concept...

LIVE NOW: FDA Announces Steps to Implement Real-Time Clinical Trials

The Food and Drug Administration announces major steps to advance the implementation of real-time clinical trials at 1:30 p.m. ET on April 28. ...

How will FDA speed up clinical trials?

FDA plans real time AI assisted trial review The FDA announced efforts intended to make clinical trials more efficient, starting with reviewing data in real time from trials conducted by sponsors. The initiative is positioned as a way to reduce “dead time” in the drug development process, when…

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…