The FDA has issued a draft guide to clarify how evidence from a sole clinical investigation can be used as substantial evidence to approve new drugs. This draft guide is in continuation of guidance from 1998 and 2019 and specifies that the amount of confirmatory evidence required will depend on the results of the single clinical investigation. The FDA encourages early communication with sponsors for this process. The draft also details how data from clinical trials, related indications, approved drugs of the same class, and real-world evidence (RWE) may qualify as confirmatory evidence. The FDA advises sponsors to discuss plans to use RWE with relevant review divisions.
From the Experts: “Whether an RWD source may be appropriate to develop RWE that serves as confirmatory evidence depends on several factors, including but not limited to the reliability and relevance of the RWD source and, when relevant, the quality of the study design and the use of appropriate prespecified statistical methods and analyses,” the draft says. “FDA recommends that sponsors discuss with the relevant review divisions any plans to use RWE as confirmatory evidence in a drug development program.”
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[Source: Endpoints News, September 18th, 2023]