ICH Releases Draft Revision of Guideline on General Trial Design and Conduct

May 13, 2019

Sponsors, sites and CROs have the chance to weigh in on the first draft revision of ICH E8 since it was adopted in 1997. Changes to trial design and conduct in the last two decades have made much of the guideline out of date.

ICH has been working to modernize its suite of clinical research guidelines since 2017, when it issued a major revision of ICH E6 and now has turned to the next guideline on its modernization schedule, ICH E8 — General Considerations for Clinical Trials.

The proposed 33-page 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. Also new to the guideline — almost triple the length of the original E8 — are sections on design elements for clinical studies and trial conduct and reporting.

ICH is seeking comments on the draft by October and plans to release the final ICH E8(R1) by June 2020.

Read the draft guideline here:

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-By Leslie Ramsey