10/11 October 2023
The E6(R3) Expert Working Group (EWG) is currently working on ICH´s Guideline on Good Clinical Practice (GCP) to address the application of GCP principles to the increasingly diverse trial types and data sources. To update international parties on the EWG’s progress ICH hosted a web conference in May. According to the ICH, E6(R3) will include two annexes that are intended to be relevant:
Together with the updated principles, these materials will represent ICH E6(R3).
In April this year the ICH Management Committee already made available a draft version of the updated ICH E6 principles that are currently under development. According to the ICH, the principles should be considered to assure ethical trial conduct, participant safety, and reliable results of clinical trials. The EWG is not taking public comments on the principles at this stage. However, ICH hosted a web conference in May to update international parties on the EWG’s progress to revise the principles and published a conference report. The report highlights key issues from the EWG and themes raised by stakeholders during the public web conference.
In addition, as the first step towards ICH´s GCP Renovation, the final ICH E8(R1) guideline reached Step 4 of the ICH Process. It provides guidance on the clinical development lifecycle, including designing quality into clinical studies.
The attendees of the web conference provided multiple comments and questions for EWG consideration. The key themes included the following:
The EWG will take the comments and questions received into consideration for the revision of ICH E6.
The Report and the Video Presentation are available under E6(R3) GCP on the ICH Efficacy Guidelines website.