BRIEF—FDA issues draft guidance related to drug and biologics clinical trials

The US Food and Drug Administration issued a draft guidance for industry titled, “ Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.”

This guidance makes recommendations to sponsors and investigators considering the use of externally controlled clinical trials to show evidence of the safety and effectiveness of a drug.

The guidance provides stakeholders with considerations for designing and conducting externally controlled trials that use patient-level data (ie, information on individual people, such as medical and treatment history) to study the effectiveness and safety of drugs, including threats to the validity of trial results from sources of potential bias.

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.

This guidance also describes considerations for communicating with FDA and ensuring the agency has access to data from an externally controlled trial.