FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development

"Efforts to devise more informed and productive clinical research programs, while also addressing demands for expanded access to experimental therapies, has focused attention on the role of inclusion/exclusion criteria in clinical research. Sponsors design clinical trials to demonstrate efficacy of a drug on a target population, usually including sufficient subgroups to support broader product use. More innovative and adaptive trial designs may facilitate including certain rare disease populations and demographic minorities that also may benefit from treatment, but with an eye to avoiding requirements that could add to the cost and challenges in conducting necessary studies.

FDA is exploring these issues, as discussed at a recent public workshop on Evaluating Inclusion and Exclusion Criteria in Clinical Trials in Washington, D.C., organized by the Duke Margolis Center for Health Policy in collaboration with FDA. While these issues have been reviewed frequently in the past, recent legislation authorizes further assessment of FDA eligibility policies and of National Institutes of Health (NIH) research standards."