ASK JEAN: What is the ICH Renovation?

Dear Jean,

What is ICH Renovation?

The International Council for Harmonization (ICH) Reflection Paper on Good Clinical Practice (GCP) was coined “Renovation” and was endorsed by the Assembly in January 2017.  It describes the ICH proposal for further modernisation of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The Renovation has been taken up by most of the regulatory authorities worldwide. The scope of the Renovation extends to several areas:

• the revision of the current E8 General Considerations for Clinical Trials,
• further revision of the E6 Guideline for Good Clinical Practice, which had last been revised in November 2016 as E6(R2).
• incorporation of the patient’s perspective and patient focused drug development (PFDD)
• development of new ICH guidelines to provide a globally harmonized approach

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 unchanged.

E8(R1) In line with the ICH Reflection Paper on GCP Renovation, ICH held public meetings before the finalization of the revised E8 Guideline, This foundational guidance document, considered core for Clinical trials, is expected to be approved in early 2021.

E6(R3) and Annexes

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. The last revision of E6 was completed and approved in 2016 and became effective in Canada May 2017 with full implementation in April 2019.

PFDD

The ICH Reflection Paper on ‘Patient-Focused Drug Development (PFDD)’ was endorsed by the Assembly in November 2020 and released to the public by Health Canada on December 15, 2020. This Reflection Paper identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety and efficiency of drug development and inform regulatory decision making. It also presents opportunities for development of new ICH guidelines to provide a globally harmonized approach to inclusion of the patient’s perspective in a way that is methodologically sound and sustainable for both regulated industry and regulatory authorities.

Health Canada, as an ICH leader and standing member, is involved in the Renovation planning initiatives, the ICH working groups, public review processes and the implementation of the new guidances at the national level.

Clinical Trials BC is hosting a provincial conference on the Modernization of Clinical Trials on January 26, 27 and 28, 2021. It highlights the modernisation elements of the ICH Guidelines related to clinical trials.

Documents & Links:

• For further information on E8(R1), including the E8(R1) Concept Paper and Business Plan, please refer to the E8(R1) page at https://www.ich.org/page/efficacy-guidelines.
• For further information on E6(R3), including the E6(R3) Concept Paper and Business Plan, please refer to the E6(R3) page  at https://www.ich.org/page/efficacy-guidelines.
• Contact Alison Orth if you are interested in Patient Engagement and PFDD projects related to Clinical Trials within British Columbia.