The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.
ICH E6 guideline for good clinical practice is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference.
ICH E6, Revision 3, will comprise of principles and 2 annexes. The principles are meant to be overarching and applicable across clinical trial designs and as the technology around us evolves. The principles and Annex-1 will reflect the content and scope of the current E6(R2) and will replace it. After the development of the principles and Annex-1, the content of Annex-2 that will provide additional consideration for “non-traditional” or innovative trials will be developed.
The Expert Working Group (EWG) for E6 comprises of ICH members and observers. Andy Fisher and I are an active part of this group as observers for PIC/S (Pharmaceutical Inspection Co-operation Scheme). The EWG has involved much engagement with stakeholders, in particular with academic researchers, and patients, through attendance at the EWG meetings and specific conferences in Europe and the USA .
The ICH E6 Guideline for Good Clinical Practice Expert Working Group is holding a free public virtual conference on 18 to 19 May 2021 to provide an update on the progress to revise this important guideline. The online conference is being convened by the Clinical Trials Transformation Initiative (CTTI; a public-private partnership co-founded by the US Food and Drug Administration and Duke University in 2007).
The EWG is holding 2 similar meetings on Tuesday 18 May from 8am to 11am EDT (2pm to 5pm CEST, 9pm to 12 am JST) and Wednesday 19 May from 6pm to 9pm JST (5am to 8am EDT, 11 am to 2pm CEST) to reach a broad global audience across time zones. The same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.
In this conference, members of the ICH E6 EWG will discuss the work-in-progress to develop principles and annexes for ICH E6 GCP (third version, or R3) that are intended to be responsive across clinical trial types and settings and remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on 19 April are designed to be flexible and applicable to a broad range of clinical trials. You can view the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.
For more information and to register for the web conference, please visit the ICH website. Please click on the “2021 Events” tab to access the announcement.
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