16.12.2021

Update on ICH E6(R3) Progress

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

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:

Annex 1 for interventional clinical trials will reflect the concepts in the current ICH E6(R2) with updates and refinements.
Annex 2 will provide additional considerations for non-traditional interventional trials.

Together with the updated principles, these materials will represent ICH E6(R3).

Background

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.

Key Topics

The attendees of the web conference provided multiple comments and questions for EWG consideration. The key themes included the following:

Informed consent – e.g. electronic consent; use of digital technology (remote consent options).
Trial design and data sources – e.g. non-interventional study designs; use of new data sources, such as real-world data and data from eHRs; use of predictive algorithms and AI.
Quality Culture – e.g. how to use critical thinking and critical to quality factors for good design and conduct, as well as quality culture.
Data management – e.g. remote source data verification and system validation.
Patient engagement – e.g. best practices to involve patients in clinical trials from study design to conduct.
Responsibilities – e.g. oversight of decentralized trials.
Monitoring – e.g. how to distinguish critical and non-critical data for risk-based monitoring.
Inspections – e.g. remote GCP inspections developed during COVID-19.
Essential documents – e.g. retention of essential information instead of essential documents.