This version of the ICH E8 General Considerations for Clinical Studies Guideline was finalised in October 2021 and sets out general principles on the conduct of clinical studies, with the objectives of the document being to: (1) Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities; (2) Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle; (3) Provide an overview of the types of clinical studies performed during the product lifecycle and describe study design elements; and (4) Provide a guide to the ICH efficacy documents to facilitate user’s access. The modernisation of ICH E8 is the first step towards the GCP Renovation initiated in 2017.

On Thursday, 31 October 2019, as part of the GCP renovation plan, ICH held a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials” hosted by FDA, United States at their headquarters in Silver Spring, MD, USA. The purpose of the public meeting was to provide information and solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials.”

Further information, including the summary report of the meeting, is available on the GCP renovation page.