ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide
Executive Summary
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.
The International Council for Harmonisation has published a document offering a sneak preview of the new overarching principles that are to form the basis of its revised guideline on good clinical practice requirements (ICH E6 (R2)).
The ICH E6(R2) serves as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
As changes to the ICH E6(R2) can have a wide and substantial impact on how clinical trials are conducted within ICH member regions and beyond, the ICH management committee said it was publishing a “draft, work-in-progress version of the updated principles” to facilitate transparency and common understanding of the issues involved.
The updated principles, the ICH explained, are “interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials.”
The new principles are designed to be flexible and applicable to a broad range of clinical trials, including decentralized trials. They aim to support improved and more efficient approaches to trial design and conduct, such as trials involving the use of innovative digital health technologies.
The principles document covers a wide variety of issues ranging from ethical considerations, informed consent, quality considerations to documentation of trial results.
The US-based Association of Clinical Research Organizations (ACRO) welcomed the draft principles, especially the “attention to innovative digital health technologies and the aim of ensuring that principles for clinical trial conduct keep pace with advancing technological developments.”
“We were pleased to see discussion of the value of bringing trials to participants and their communities,” Karen Noonan, ACRO’s senior vice president of global regulatory policy told the Pink Sheet.
Public Consultation
The draft document is not open to comment as yet. The ICH explained that it follows a five-step process to support the development and implementation of harmonized guidelines. The principles document is currently in Step 1, which involves preparing a consensus draft of the technical document.
The document will be issued for public consultation when it moves to Step 2 of the process, which involves confirmation of consensus on the technical document and adoption of the draft guideline by ICH regulatory members.
In addition, the ICH plans to organize on 18-19 May a global web conference to present the current draft of the GCP principles as a work in progress.
GCP Renovation
The ICH E6(R2) guideline was last revised in 2016 and there have been calls to update it to take account of how clinical trial conduct was changing in practice. This prompted the ICH to launch a GCP “renovation” project in 2017. (Also see "ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources" - Pink Sheet, 24 Feb, 2017.)
As the ICH GCP framework comprises two guidelines – ICH E6 and ICH E8 (on general considerations for clinical trials) – under the renovation project the ICH decided to first address broader concerns relating to the principles of study design and how to plan for an appropriate level of data quality by proposing changes to the E8 guideline. (Also see "ICH Plans Revamp Of Guidance On Clinical Trial Data Quality" - Pink Sheet, 13 May, 2019.)
At present, the ICH is rewriting E6(R2) to address how GCP principles should be applied to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs. The revised guideline would also provide flexibility, where appropriate, to facilitate the use of technological innovations in clinical trials.
When the revision of E6(R2) is complete, it will result in:
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the overarching GCP principles document (the draft version of which has just been published);
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Annex 1, focused on interventional clinical trials; and
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Annex 2, which would outline additional considerations for non-traditional interventional clinical trials.
The principles document and Annex 1 are being developed simultaneously because together they will form the new E6(R3) (replacing the current E6(R2)), but work on preparing Annex 2 will be undertaken separately.