Practical Strategies For Diverse Trial Recruitment

By Dr. Andrew Warmington, Manufacturing Editor, Citeline

The implementation of diversity action plans (DAPs) in clinical trials has become essential for pharmaceutical companies to enhance the participation of underrepresented racial and ethnic groups, following the Food and Drug Omnibus Reform Act (FDORA). The FDA's forthcoming guidance, due by June 2025, underscores the critical need for diverse trial populations to ensure the efficacy and safety of medications across demographics. Companies are now required to establish enrollment goals based on ethnicity, race, sex, and age, while addressing historical mistrust and logistical barriers that hinder participation among minority populations. Recruitment strategies have grown more complex and costly, with many trials struggling to meet diversity targets despite enhanced outreach efforts. The COVID-19 pandemic has shifted perceptions of the pharmaceutical industry, revealing the potential for expedited regulatory processes and reduced barriers for trial participants. To foster trust and improve recruitment, companies are leveraging technology and grassroots initiatives. Looking ahead, the FDA is expected to enforce transparent recruitment strategies, prompting a collaborative effort among regulatory bodies, the pharmaceutical sector, and patients to promote health equity and accessibility in clinical trials.