FDAnews Device Daily Bulletin

Draft Guidance Spells Out Strategy to Increase Diversity in Clinical Trials

June 28, 2016

Manufacturers need to increase diversity of subpopulations when designing clinical trials to obtain an unbiased estimate of treatment effect, the FDA says.

New draft guidance assists sponsors in developing strategies for evaluating and reporting age, race and ethnicity data on device safety, effectiveness, benefit-risk profile, study design and device labeling.

The guidance shows sponsors what demographic variables should be considered in study designs. It covers collection and consideration of subpopulation data during clinical study design, outlining how to interpret subgroup data, pointers on how to enroll diverse populations and to maintain clinical follow-up.

View today's stories