OECD Recommendation on governance of clinical trials

The OECD Recommendation on the Governance of Clinical Trials provides a harmonised international framework aimed at reducing administrative complexity — especially for non-commercial and multinational trials — by embedding a risk-based, proportionate oversight methodology.

Scope and Content:

• Two complementary approaches to risk assessment: 
  (A) a stratified approach based on the marketing authorisation status of the investigational medicinal product (IMP), and 
  (B) a trial-specific approach addressing additional factors such as diagnostic procedures, specific populations and informed consent.
• Three stratified risk categories: 
  Category A (authorised IMP, used as licensed), 
  Category B (authorised IMP, used off-label, with two sub-categories based on evidence support)
  Category C (unauthorised IMP), with modulating factors including product novelty and innovative nature.
• Detailed principles on how risk category should influence ethics review, regulatory approval, safety reporting, indemnification and insurance, IMP management, documentation and quality management.
• Guidance on developing common risk assessment tools for use across jurisdictions and in multinational trials.
• Implementation report (2020) demonstrating growing adoption of risk-based approaches among OECD adherents, while highlighting remaining inconsistencies between jurisdictions.

Useful for investigator-initiated clinical studies to:

• Understand the risk categorisation logic that underlies EU Clinical Trial Regulation (EU CTR 536/2014) and comparable frameworks.
• Advocate for simplified procedures and reduced administrative burden for low-risk academic trials.
• Use risk categories as a basis for proportionate quality management and monitoring plans.