The modernized revision adds a new section on designing quality into clinical studies that focuses on the need to identify a basic set of “critical-to-quality” factors that the guideline defines as “attributes of a study whose integrity is fundamental to the protection of study subjects, the reliability and interpretability of the study results and the decisions made based on the study results.” Those factors should be adaptable to a variety of trial designs, the guideline says.
The new document also emphasizes the importance of patient centricity in trial development. “Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment and promote adherence, which should continue throughout the duration of the study,” the guideline says.
ICH is seeking comments on the draft by October and plans to release the final CIHE8 (R1) by June 2020.
ICH Releases Draft Revision of Guideline on General Trial Design and Conduct