The FDA is seeking its own set of comments on ICH E8(R1) draft guidance issued by the International Council for Harmonisation earlier this year on designing quality clinical trials.

The 40-page document emphasizes good design of trials to drive quality rather than “an overreliance on retrospective document checking, monitoring, auditing or inspection.” It focuses on identifying critical to quality factors and risk mitigation and emphasizes that patients should be consulted early in the design process.

By involving patients in the early stage of study design, researchers are likely to “increase trust in the study, facilitate recruitment and promote adherence, which should continue throughout the duration of the study,” ICH says.