ICH good clinical practice (E6)
The international standard for how a clinical trial must be designed, run, recorded and reported so that regulators in the United States, Europe, Japan and now China will accept its data; the third version was adopted in 2025 to fit trials that use electronic records and run across many countries.
Overview
International, harmonised guideline adopted into law by regulators. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was founded in 1990 by the regulators and industry associations of the United States, the European Union and Japan and has since admitted regulators including China's NMPA (2017), Brazil, South Korea and others. Its E6 guideline on good clinical practice was finalised in 1996, revised as E6(R2) in 2016 to add risk-based quality management, and replaced by E6(R3), adopted in January 2025 and applied in the EU from July 2025. Primary text: the ICH efficacy guidelines page; regulators make it binding through their own rules (21 CFR parts 50, 56 and 312 in the US, the Clinical Trials Regulation in the EU).
What it covers: the responsibilities of sponsors, investigators and ethics committees; informed consent; protocol and investigator's brochure content; data handling, monitoring and audit; safety reporting; and record retention, so that a trial's data are credible and participants' rights and safety are protected. E6(R3) reorganised the guideline around principles, quality by design and proportionate risk-based oversight, and addresses decentralised elements, electronic data and real-world data sources. Companion guidelines such as E9 on statistical principles and its 2019 addendum on estimands, and E17 on multi-regional trials, govern how oncology endpoints are analysed.
Why it matters and the arguments: a phase 3 cancer trial run to ICH GCP can support approval in every ICH region, which is what makes global development and Project Orbis possible; academic groups have long complained that E6 was written for industry trials and made low-risk pragmatic trials needlessly expensive, a criticism R3's proportionality aims to answer. It is the practical successor to the Declaration of Helsinki in regulatory texts.
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