Thursday, December 7, 2023

Reagan-Udall Foundation Report on Real World Evidence Generation, PostMarket, FDA

Last week was the 17th annual meeting of the Personalized Medicine Coalition (PMC), which has also posted talks on its public YouTube channel here.  For me, one of the best talks was by Amy Abernethy MD of Verily, on a broad vision for cross-silo data collection for registries and post marketing data.  

She highlighted a November 2023 report on RWE and FDA, from the Reagan-Udall Foundation (home page here).

Here are two articles about the 61-page report:

Download the PDF report here:

AI Summary - 

The Reagan-Udall Foundation's report highlights the need for significant changes in the post-market evidence generation system, which is currently costly and inefficient. 

Key recommendations include simplifying protocol objectives, enhancing patient involvement, and bettering adverse event reporting. 

The report proposes the FDA to lead a task force with NIH, CMS, and Health IT Office members to set new standards for post-market evidence generation. 

FDA chief Robert Califf supports these suggestions, stressing the importance of streamlining clinical trials, especially in fast-evolving areas like precision medicine. The report advocates for a new paradigm to efficiently generate evidence regarding the safety and efficacy of existing medical products.