Sunday, July 14, 2024 4:52:13 PM
Consistent with FDA’s prior guidance on the use of RWD to develop RWE for regulatory decision-making5, the External Controls Draft Guidance clarifies that multiple sources of patient-level data could potentially serve as the control arm data in an externally controlled clinical trial, including but not limited to data from other clinical trials, registries, natural history studies, electronic health records (“EHR”), and medical claims data.
Game over for you.
https://www.kslaw.com/news-and-insights/fda-issues-draft-guidance-on-external-controls-in-clinical-trials-to-support-safety-and-efficacy-of-a-drug
Funny how you keep refusing to provide any source what you keep claiming
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