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USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products

The guidance gives sponsors and investigators recommendations on how to demonstrate a drug's safety and effectiveness through externally controlled clinical trials.

A set of considerations is included in the guidance for designing and conducting externally controlled trials using patient-level data (i.e., information about an individual's medical history, treatment history, etc.) to assess the safety and effectiveness of drugs, including potential bias threats that may threaten the validity of trial results.

The external data can include data from other clinical trials or from real-world data sources such as registries, electronic health records, or medical claims. As a result of the recommendations in this guidance, sponsors will be able to advance opportunities and improve efficiencies, as well as design and conduct more efficient and effective externally controlled trials.

The guidance also describes how to make sure FDA has access to externally controlled trial data and how to communicate with the agency.

Click this LINK to know more information considerations to support regulatory review, etc.


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