Karen R. Sepucha

2 weeks ago | kevinmd.com | Stephanie Ernst |Karen R. Sepucha |Bonnie Friedman |Sara L. Merwin

In January 2025, the International Council for Harmonisation (ICH) formally adopted the updated E6(R3) Good Clinical Practice (GCP) guidelines. Annex 1 and the revised 12 principles are already in effect. Annex 2 arrives in July. This is not just regulatory housekeeping. It is a clear message to the research world: Meaningful patient involvement is no longer aspirational. It is expected. For decades, clinical research positioned patients as participants, not partners.