Under the FDA Reauthorization Act of 2017, the FDA received a mandate to promote practices that lead to clinical trials better reflecting the population most likely to use the drug. Based on discussions at a public meeting held in April 2018, CDER’s Office of Medical Policy issued a draft guidance in June 2019 with the agency’s recommendations for enhancing the diversity of clinical trial populations. This guidance focuses primarily on broadening (or countering the tendency to narrow) clinical trial eligibility criteria to increase this diversity. The recommendations include inclusive trial practices and changes to trial design, methodology, and conduct. One point I applaud is making trial participation less burdensome to patients. Even routine participation in receiving healthcare is time-consuming, difficult, and repeatedly changing – one can only imagine the difficulties faced by trial participants, especially those who need to travel long distance to the trial center. The Expanded Access Program is referenced, and there is also a welcome section on approaches for rare disease trials. The appendices contain lists of related guidance and initiatives which could be enhanced with document links. Comments may be submitted until 06AUG2019 at the Federal Register notice.  

July 2022 Note: This guidance was issued as a Level 1 final in November 2020.

Text Copyright © 2019 Katrina Rogers