E6(R3) Good Clinical Practice (GCP): FDA's Current Thinking on Clinical Trials

In January 2025, the International Council for Harmonisation (ICH) finalized the Good Clinical Practice (GCP) E6(R3) framework, introducing key concepts such as risk proportionality, quality by design (QbD), and participant-centered research by replacing "subject" with "participant." This article offers in-depth education to equip professionals with essential insights on these transformative guidelines and describes the FDA's current thinking on the framework. This was written for the Public Responsibility in Medicine & Research (PRIM&R) blog, Ampersand.