Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.
BACKGROUND: Improving diversity in clinical trials is essential in order to produce generalizable results. Although the importance of representation has become increasingly recognized, identifying strategies to approach this work remains elusive. This article reviews the proceedings of a multi-stakeholder conference about the current state of diversity in clinical trials and outlines actionable steps for improvement. METHODS: Conference attendees included representatives from the United States Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups. At this virtual event, attendees were asked to consider key questions around best practices for engagement of underrepresented populations. RESULTS: Community engagement is an integral part of recruitment and retention of underrepresented groups. Decentralization of sites and use of digital tools can enhance the accessibility of clinical research. Finally, improving representation among investigators and clinical research staff may translate to diverse clinical trial participants. CONCLUSION: Improving diversity in clinical trials is an ethical and scientific imperative, which requires a multifaceted approach.
Duke Scholars
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- United States Food and Drug Administration
- United States
- Research Personnel
- Public Health
- Humans
- General Clinical Medicine
- 42 Health sciences
- 32 Biomedical and clinical sciences
- 11 Medical and Health Sciences
Citation
Published In
DOI
EISSN
Publication Date
Volume
Start / End Page
Location
Related Subject Headings
- United States Food and Drug Administration
- United States
- Research Personnel
- Public Health
- Humans
- General Clinical Medicine
- 42 Health sciences
- 32 Biomedical and clinical sciences
- 11 Medical and Health Sciences