ICH Guideline for Clinical Study Considerations

The International Council for Harmonization has released for public comments a revised draft guideline entitled “General Considerations For Clinical Studies E8(R1).” The document focuses on designing quality into clinical studies and it is intended to:

• Describe internationally accepted principles and practices for designing and conducting clinical studies that will lead to submissions being accepted by international regulatory authorities.
• Provide recommendations on quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to a study’s quality, and managing risks to those factors during study conduct.
• Provide an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support quality factors are critical to ensuring human subject protection, data integrity, and the reliability of results.