In November 2020, the FDA released guidance on enhancing diversity in clinical trials. The guidance, first issued as a draft in 2019, provides the agency’s thinking on steps to broaden eligibility criteria in clinical trials. Although patient diversity is a concern for pharma and biotech companies, the solutions to recruiting more diverse patient populations are not easy to come by. It seems clear, however, that recruiting minority patients will involve education, building trust, a different type of outreach, and engaging with new site partners.
This content collection on Patient Diversity shares some of the efforts being made by sponsor companies to change their recruitment paradigm and include a more representative patient population. I hope you enjoy reading and learning from these insights as much as I enjoyed putting them together.
- Ed Miseta, Chief Editor