The FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies,” to assist those that design clinical studies by outlining the internationally accepted principles and practices for clinical studies of drugs and biologics. It also aims to promote quality studies for submission to regulatory authorities, while accounting for necessary flexibility. The guidance offers 3 significant updates from the 1997 guidance, “E8 General Considerations for Clinical Trials” including:
- Addresses study quality, while promoting efficiency
- Addresses a broad range of study designs and data sources
- Provides updated cross-referencing to other relevant ICH guidance
See the complete guidance to review detailed sections on designing quality into clinical studies, drug development planning, data sources for clinical studies, and more.
E8(R1) General Considerations For Clinical Studies - Guidance for Industry
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