Unblinded: A Clinical Trial Podcast ICH E6(R3): Shifting the Paradigm from Process to Purpose
Jan 15, 2026
Cheryl Grandinetti, FDA clinical policy leader with a pharmacy background, and Lisbeth Bregnhoj, Danish GCP inspector and pharmacist, talk ICH E6(R3) changes. They discuss the new data governance chapter and shifting from rigid processes to purpose-driven, risk-based trial design. Conversations cover defining Critical-to-Quality factors, harmonizing regional language, and reducing site burden while improving inspection alignment.
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Global Harmonization Required Heavy Compromise
- Developing ICH guidelines is resource-intensive and requires global compromise and translation-ready language.
- COVID forced long remote collaboration, increasing the challenge of harmonizing diverse regional perspectives.
Data Governance Is Now Central
- ICH E6(R3) adds a new, explicit data governance section that shares responsibility between sponsors and investigators.
- This bridges gaps between E6 and E9 and recognizes that not all data carry equal importance for trial quality.
Align CtQs Across All Parties
- Do document and align on Critical-to-Quality factors across sponsors, service providers, and investigators.
- Ensure everyone focuses on the same CtQs so oversight and execution target true trial risks.