Trials by design: inside the new good clinical practice guideline
Good clinical practice (GCP) is the rulebook that governs how trials on human volunteers are designed, run, recorded and reported. Every sponsor, contract research organization (CRO) and investigator site works to it, and every regulator inspects against it. It rarely makes headlines, but when the text changes, the daily mechanics of drug development change with it.
The rulebook has just changed. The International Council for Harmonisation (ICH), the body that brings together drug regulators and industry from the USA, Europe, Japan and a growing list of other regions, adopted the third revision of its GCP guideline, known as E6(R3), on January 6, 2025. According to ICH, the document had been in development since a 2019 concept paper.
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