FDA Inclusion/Exclusion Criteria Workshop

FDA has published a report summarizing the major points explored with stakeholders at a 4/16 public workshop on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The report says the workshop “provided an opportunity for representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a variety of topics related to eligibility criteria in clinical trials. The workshop addressed the underrepresentation of various populations in clinical trials, how eligibility criteria affect patient access to investigational drugs and enrollment in clinical trials, alternative clinical trial designs that may increase the enrollment of diverse populations, and whether FDA’s expanded access program could provide an opportunity to facilitate access to investigational products.”

The agency says that strategies and recommendations from the workshop will help inform future activities on the topic.