The update of the ICH E6 (R3) guideline on Good Clinical Practice (GCP) is currently in its final stages and is expected to come into force during 2025. Its final release will depend on the regulatory authorities of each country involved in the ICH.
Since the first development of the guideline in 1996, there has been one major revision: ICH E6 (R2), published in 2016. This update addressed significant changes in the clinical research landscape, including the increasing complexity and costs of clinical studies, as well as the availability of electronic health data.
Now, 8 years later, the new revision, ICH E6 (R3), aims to modernise and enhance the effectiveness of international standards for the design, conduct, recording, and reporting of clinical studies involving humans. More specifically, ICH E6 (R3) seeks to provide greater flexibility to accommodate technological advancements and innovative study designs.
Additionally, the revised guideline promotes a collaborative approach to clinical studies, clarifying roles and responsibilities shared between sponsors, investigators, and regulatory authorities.
The ICH GCP Guideline is structured into Principles and 2 Annexes, which expand on these Principles with specific details for different types of clinical trials:
• Annex 1: Primarily addresses traditional clinical trials.
• Annex 2: Provides additional considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic designs, and/or real-world data (RWD).
Currently, Annex 2 is open for public consultation until 25 February 2025. Stakeholders are encouraged to provide feedback on the draft guideline to identify any missed considerations or to clarify potential ambiguities in the text. Further details are available in the draft document.