The Reagan-Udall Foundation asserts in a new report that the current post-market evidence generation system is expensive and time-consuming, with an urgent need for substantial changes. Recommendations include simplifying protocol objectives, increasing patient participation, and improving adverse event reporting. The report also suggested the FDA lead a task force, including members from the NIH, CMS, and the Office of the National Coordinator for Health Information Technology, to establish post-market evidence generation standards. FDA chief Robert Califf welcomed the report’s suggestions and emphasized the necessity of streamlining clinical trials in the US, particularly in rapidly progressing fields such as precision medicine. Establishing a new paradigm that encourages efficiency in evidence generation for existing medical products’ safety and efficacy was also promoted.
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[Source: Endpoints, November 15th, 2023]