Thursday, July 03, 2025 10:30:37 PM
““this guidance focuses on the use of patient-level data from other clinical trials or from real-world data (RWD) sources, such as registries as well as electronic health records (EHRs) and medical claims.” ”
Page 1 of PDF. Clearly says “other clinical trial as well as RWD sources “
Read it to your hearts content
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products
Not sure when it will be finalized or if there will be any change to it . But there you have it .
Page 1 of PDF. Clearly says “other clinical trial as well as RWD sources “
Read it to your hearts content
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products
Not sure when it will be finalized or if there will be any change to it . But there you have it .
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