Summary
The winds of change are literally blowing through the clinical research landscape. With the third version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH GCP E6(R3)) now formally adopted and in effect since 15 August 2025 in Switzerland (Annex 2 is to be adopted soon and will come into effect no earlier than 2026), the clinical research community is undergoing a period of rapid transition – and a bit of turbulence. The revised ICH GCP E6(R3) represents a shift in how we approach quality, risk, oversight, and data governance. The overarching aim of this regulatory shift is to promote a more participant-centred, flexible, and fit-for-purpose approach to clinical research that results in higher transparency and accountability and is better suited for advances in technology. We hope RA Watch 10 will help the clinical research community better understand, navigate, and even soar through the current winds of regulatory change.
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