The FDA has provided guidance supporting the use of real-world data in the development of diversity plans for clinical trials. These plans may involve the implementation of more inclusive or broader eligibility criteria to enhance the participation of populations historically underrepresented in clinical trials. This study examined the impact of expanding eligibility criteria on the diversity of participants with advanced non-small lung cancer (advNSCLC).
Why this matters
Expanding eligibility criteria may increase the representation of non-Latinx Black, Latinx, older, and female patients in clinical trials. A more diverse population of eligible participants with expanded eligibility criteria may exhibit distinct clinical outcomes compared to a cohort with more stringent eligibility criteria and better reflect real-world patient populations.