The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data.

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The new E6(R3) is deemed to tackle the evolving clinical trial design and use of technology in clinical research, the diversity of data sources, testing facilities, service providers, and other merging complexities of the current clinical trial environment. The update of E6 will also bring forward an advanced concept of a risk-based approach in the design and conduct of clinical trials, although E6(R2), was already focused on that aspect. Moreover, the revised E6 will take into consideration the diversity of clinical trials, as clinical trials can vary greatly and certain aspects of GCP may not be applicable to every trial.

According to ICH, “E6(R3) will be composed of an overarching principles and objectives document, Annex 1 (interventional clinical trials), and Annex 2 (additional considerations for non-traditional interventional clinical trials). The overarching principles and objectives document and Annex 1 will replace the current E6(R2).”

“The proposed revision to ICH E6 would likely primarily benefit innovators who typically conduct clinical trials, such as those in the pharmaceutical and biotech sectors. Work will also inform innovators who are utilizing or exploring the use of diverse trial types and the data sources being employed to support regulatory and healthcare related decision-making on drugs. The revised E6 will highlight that achieving GCP principles and objectives can be accomplished through the use of multiple tools and methods. It will also highlight that the implementation of GCP principles should be a thoughtful, deliberative, and risk-based process.”

Final Business Plan, ICH E6(R3): Guideline for Good Clinical Practice, Dated 17 November 2019, Endorsed by the Management Committee on 18 November 2019.

E6(R3) is expected to be released in the fall of 2021.

For more details, please see the ICH Final Business Plan on E6 revision and the Efficacy Guidelines from ICH.