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GCP Renovation and Revision: Preparing for ICH E6(R3)

The International Council for Harmonisation (ICH) E6(R2) guideline for good clinical practice (GCP) is the current global standard for clinical trials. However, the ICH currently has a working group tasked with revising it (referred to as “R3” as it is the third revision).

According to the November 2019 Final Concept Paper for ICH E6(R3), the working group is tasked with a full rewrite and reorganization of the E6(R2) guideline. The working group will consider the application of the GCP principles to the growing diverse types of clinical trials and data sources being used. The group will also update E6 to provide flexibility when appropriate “to facilitate the use of technological innovations in clinical trials” (ICH 2019).

The plan includes replacing E6(R2) with an “overarching principles and objectives document and Annex 1 (for clinical trials)” and then later an Annex 2 will be developed to contain additional considerations for non-traditional interventional clinical trials (ICH 2019). The revision work is ongoing, but according to the work plan the Principles and Objectives/Annex 1 (which is the ICH E6 replacement) should be drafted by December 2021, and potentially adopted by November 2022 (ICH 2020). The subsequent Annex 2 drafting should begin in June 2022.

Beyond revising the ICH E6 guideline, the working group is also going to consider revisions to ICH E8. This is part of a larger effort referred to as “GCP Renovation.” The aim is a modernization of guidelines that will enable “a diversity of approaches that are relevant and adaptable to the variety of clinical trial designs and innovative technologies” (ICH 2019). The revisions also plan to address gaps and inconsistencies between the current guidelines (ICH 2019).

During the COVID-19 pandemic, there have been a lot of accelerated adoptions of processes and technologies. To protect human subjects and speed up clinical trial progress, regulators are more accepting and, in some cases, even encouraging adoption of things like decentralized clinical trials (DCTs), obtaining consent remotely or virtually, virtual study visits, and use of mobile technologies. The GCP renovation to the international guidelines will surely reflect this new era in clinical trials.

CITI Program Content Updates

Once the new guidelines are available, CITI Program will update any affected modules. We will also develop any new training as applicable.