The US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) has launched an initiative to improve access to clinical trials for populations that have historically been underrepresented in clinical research.
The OCE Equity Program is an expansion of Project Equity, which was established by the OCE in 2021 to address underrepresentation of racial and ethnic subgroups in clinical research. Prior to Project Equity, data published by the OCE for new drug trials approved between 2011 and 2017 showed that more than 80% of participants were white.
Published in 2022, the FDA’s draft guidance gave recommendations for sponsors to submit diversity plans to the regulator detailing how representative populations would be enrolled into clinical trials for a new investigational drug.
In addition to racial and ethnic minorities, the OCE Equity Program will continue efforts to improve trial access for individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic or cultural barriers to healthcare services.
The programme will also see the OCE engage with stakeholders on research, policy and education initiatives and conduct analyses of trial data from diverse clinical trials to evaluate outcomes across subgroups.
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