ICH General principles for planning and design of multi-regional clinical trials E17

The ICH E17 Guideline from the International Council for Harmonisation provides international guidance on the planning, design, and interpretation of multi-regional clinical trials (MRCTs). It focuses on strategies for trial population selection, statistical analysis, regional representation, and regulatory alignment, ensuring that global studies produce reliable and interpretable evidence applicable across diverse patient populations. The guideline supports sponsors, investigators, and regulators in harmonizing trial standards, improving efficiency, and facilitating global drug development.

Key features and content include: 

• Framework for multi-regional trial design: Offers principles for selecting regions, populations, and study centers to ensure representativeness and validity.
• Regulatory alignment: Provides guidance for meeting expectations of multiple regulatory authorities, supporting global approval pathways.
• Statistical and analytical considerations: Outlines methods for pooled analyses, bridging studies, and regional heterogeneity assessment.
• Ethical and operational guidance: Ensures participant protection, consistent study conduct across regions, and quality management in complex international trials.