The ICH Reflection Paper on Good Clinical Practice (GCP) “Renovation” endorsed by the Assembly in January 2017, describes the ICH proposal for further modernisation of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the renovation includes the revision of the current E8 General Considerations for Clinical Trials, and the further revision of the E6 Guideline for Good Clinical Practice, which had last been revised in November 2016 as E6(R2).
The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain.
E8(R1) Global Meeting
In line with the ICH Reflection Paper on GCP Renovation, ICH held public meetings before the finalization of the revised E8 Guideline, including a Global Meeting which was held on 31 October 2019.
E6(R3) Stakeholder Engagement Approach
In line with the Reflection Paper on Renovation of Good Clinical Practice and the ICH E6(R3) Concept Paper, an approach was developed and approved in April 2020 to engage stakeholders for the revision of ICH E6(R3) with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials. A summary of the E6(R3) Stakeholder Engagement Approach is available in the documents section.
ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials
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.” The summary report, the agenda and the slides of the meeting are available in the documents section.
