ICH GCP Draft Guideline

Following the previously published ICH E6 draft principles the ICH E6(R3) Expert Working Group (EWG) has developed a revised Guideline on Good Clinical Practice (GCP). The ICH E6(R3) draft guideline is now available for public consultation. It intends to encourage the use of innovation and technologies that have the potential to make clinical trials more efficient. The deadline for EU comments is 26 September 2023.

Background

ICH E6 is currently the only agreed upon guideline that is harmonized among the global regulatory community to support the responsible and efficient conduct of clinical trials.

In April 2021, acknowledging the wide and substantial impact of ICH E6, and prior to the reaching of ICH Step 2 (which was subsequently reached in May 2023), the ICH Management Committee made available a draft version of the updated principles from the ICH E6(R3) EWG in order to facilitate transparency and common understanding.

Draft ICH GCP Guideline

The revised guideline is composed of principles with specific details for different types of clinical trials. The guideline applies to interventional clinical trials of IMPs (Investigational Medicinal Products) that are intended to be submitted to regulatory authorities and may also be applicable to other interventional clinical trials that are not intended to support marketing authorization applications in accordance with local requirements.

It contains a new section on data governance and revised parts on records and reports in the investigator and sponsor sections, but there are multiple other important updates, additions and revisions in order to accommodate new trial and data types. For example, the data originator may be a human (e.g., the participant or trial staff), a machine (e.g., wearables and sensors) or an electronic transfer of data from one system to another (e.g., extraction of data from an electronic health record (eHR) or laboratory system).

GMP for IMPs

IMPs used in a clinical trial should be manufactured in accordance with Good Manufacturing Practice (GMP) and be stored, shipped, handled and disposed in accordance with the product specifications and the trial protocol. In particular, the following applies:

• Measures should be in place to ensure that the IMP provided to trial participants retains its quality.
• IMPs should be used in accordance with the protocol and relevant trial documents.
• Manufacturing, handling and labelling of IMPs should be undertaken in a manner that aligns with treatment assignment and maintains blinding.
• IMP labelling should follow applicable regulatory requirements.
• Adequate measures to ensure that the IMP is handled and shipped appropriately should be implemented.

Annexes

The ICH announced that the revised ICH E6 Guideline will include the following 2 Annexes:

• Annex 1 (which is already included in the draft document) is intended to provide information on how the E6 concepts can be appropriately applied to clinical trials.
• Annex 2 providing additional considerations for interventional clinical trials (work on Annex 2 has just been initiated, with an Annex 2 Concept Paper approved in May 2023 by the ICH Management Committee). This will include, for example, decentralised elements and real-world data (RWD) sources (e.g., the use of registries, eHRs, hospital data, pharmacy and medical claims data or wearables).

For more information please check the ICH E6 website and the MHRA´s Inspectorate's Blog ICH E6 (R3) Good Clinical Practice.