Good Clinical Practice Draft Guidance Revealed for Clinical Studies

FDA announced the availability of the draft guidance, E6(R3) Good Clinical Practice (GCP) on June 5, 2023. Prepared by the International Council for Harmonisation (ICH), the GCP guideline provides a standard for facilitating a mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. According to the guidance, the document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

This includes, but is not limited to, fostering a quality culture and designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders. Further, this guideline is applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.

The principles outlined in the guidance are intended to apply across clinical trial types and settings and to remain relevant as technological and methodological advances happen, according to the guidance. It should also be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials.