ICH E6, which establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants, has recently been updated. R3 introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and methodological advancements.
The revision includes three elements:
a document presenting overarching principles and objectives. These are intended to support efficient approaches to trial design and conduct. They are interdependent and should be considered in their totality to assure ethical trial conduct and reliable results;
Annex 1 is intended to provide information on how the principles can be appropriately applied to clinical trials;
Annex 2, the goal of which is to offer GCP considerations for clinical trials with various design elements and data sources, ensuring that these are fit for their intended purpose. The Annex covers matters such as pragmatic clinical trials and decentralized clinical trials, as well as those trials that incorporate real world data sources.
The principles document and Annex 1 have already entered into effect. Annex 2 will enter into effect on 15 January 2027.