US FDA’s External Controls Guidance Should Include Hybrid Designs, Experts Say

23 Aug 2023

Also, FDA audits of vendors who curate and de-identify data could be a way of establishing data provenance without providing access to original patient records, which could trigger consent and privacy issues, experts said during a roundtable sponsored by the Clinical Research Data Sharing Alliance.

'Gold star certification' of data vendors is one way of overcoming privacy and consent issues raised by the FDA's external controls guidance. • Source: Shutterstock

The US Food and Drug Administration should expand the scope of its recent draft guidance on externally controlled trials to include hybrid approaches in which an external arm supplements a concurrent control in a randomized study, representatives from industry and academia said.

In addition, FDA audits of data providers that de-identify and curate data could satisfy requirements for establishing data provenance and reliability and should be considered in place of the guidance's...

US FDA’s External Controls Guidance Should Include Hybrid Designs, Experts Say

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