FDA Draft Guidance on Externally Controlled Trials for Drug and Biological Products released today

Today, US FDA released a Draft Guidance for Industry on "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products".?

"In an externally controlled trial, outcomes in participants receiving the test treatment according to a protocol are compared to outcomes in a group of people external to the trial who had not received the same treatment".?

"Although various sources of data can serve as the control arm in an externally controlled trial, 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".

The 20-page document is in public consultation till the 02May23.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products