White Paper

Patient Diversity In Clinical Research: Identifying Challenges, Opportunities, And Best Practices

Source: Biorasi

By Darshan Dave, Senior Medical Writer, Biorasi


Ensuring diversity in clinical trials is crucial for producing comprehensive and reliable data and reducing healthcare inequities. Currently, there is a lack of representation of minority groups in clinical trials, leading to disparities in healthcare outcomes. To address this issue, strategies such as patient-centric study design, collaboration with community-based organizations, patient referrals, targeted messaging and outreach, and engaging diverse clinical sites can be implemented. The FDA has also issued guidance recommending the submission of diversity plans for medical products to improve the representation of underrepresented racial and ethnic populations in clinical research.

As regulatory organizations emphasize the importance of diverse patient participation, stakeholders in clinical trials need to adapt their protocols to include a diverse range of races, ethnicities, ages, sexual orientations, and gender identities. Sponsors can implement various approaches, such as patient-centric protocol designs and expansive clinical site networks, to enhance diversity in clinical trial recruitment. By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

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