A collaborative approach to greater diversity in clinical trials
The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Despite the introduction of US policies, beginning with the 1993 National Institutes of Health (NIH) Revitalization Act which called for the inclusion of more women and communities of colour in clinical trials, clinical trial data has remained largely based on healthier Caucasian subjects with minimal representation from minorities (African American, Latinx, Asian, Native Americans), the elderly, young, and those with co-morbidities.
To encourage more of a focus on clinically relevant populations, the US Food and Drug Administration (FDA) recently released “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” to increase participant access to clinical trials and the enrolment of underrepresented populations to ensure clinical trial data reflects the population most likely to use the drug if approved1. The guidance encourages sponsors to remove overly restrictive and legacy exclusions, broaden protocol eligibility criteria, and improve trial recruitment practices so trial data is clinically relevant for the end user.
Historical performance data, like that provided in FDA Drug Trials Snapshots, has shown that using traditional recruitment practices by themselves does not enhance the diversity of clinical trial populations. Fundamental barriers and deeply rooted mistrust of medical research motives among communities of colour require a more thoughtful and deliberate approach to participant outreach. PPD has seen recent successes in the recruitment of more clinically relevant trial populations through the implementation of patient-centered trial solutions designed to address the most common barriers to clinical trial participation among these diverse patient populations – mainly trust, understanding, awareness, access, time, and cost, especially when delivered in collaboration with organisations focused on communities of colour and community leaders to ensure optimal receptivity.