In April 2022, the FDA released a draft guidance with recommendations regarding the use of a Race and Ethnicity Diversity Plan in clinical trials to improve long-standing inequities in clinical trial accrual among historically marginalized populations who carry a disproportionate disease burden.
Within it, the FDA encourages sponsors to leverage various data sources, including real-world data (RWD), when designing clinical development programs to help mitigate these issues.
This paper explores how RWD can support the intentional design of more representative cancer clinical trials, particularly through more inclusive trial eligibility criteria.
Why this matters
Representativeness in cancer clinical trials is pivotal to ensure that clinical development programs better reflect the diversity of the patient populations and thus provide more relevant insights into safety and efficacy. High-quality RWD can inform the intentional selection of inclusive trial eligibility criteria that optimize enrollment and representativeness of study populations for cancer clinical trials. This knowledge can help close the long-overdue diversity gap between the underlying patient population and patients eligible for and ultimately enrolled in clinical trials.