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Derrik Nghiem BS 1 Eric Daar MD 2

1Oakland University William Beaumont SoM

2The Lundquist Institute

Stakeholder Perspectives on Enhancing Minority Participation in Clinical Research: Lessons from COVID-19 Vaccine Trials

The underrepresentation of minority populations in clinical research compromises health equity and the generalizability of findings. While the NIH Revitalization Act of 1993 and 2022 FDA guidelines mandated the inclusion of diverse groups, significant barriers remain. During the COVID-19 pandemic, the Lundquist Institute achieved high minority enrollment (55%–78%) in the AZD1222 vaccine trial through collaboration with a Community Consultant Panel (CCP). This study investigates the specific factors that influence minority participation from the perspective of various stakeholders.

Introduction

Aims and Objectives

  • To identify and rank the primary barriers and facilitators to minority enrollment in clinical trials.
  • To compare the perspectives of three key stakeholder groups: Infectious Disease Investigators, Clinical Research Staff, and a Community Advisory Board (CAB).
  • To provide actionable, priority-based recommendations for increasing inclusivity in future clinical research.
  • Survey Design: A structured 20-question survey using a Likert scale (1–5), categorized into three themes: Logistical (9 questions), Information/Engagement (5 questions), and Cultural/Community factors (6 questions).
  • Participants: 39 total stakeholders, including 7 Investigators, 12 Research Staff, and 20 CAB members (predominantly people of color).
  • Data Collection: Distributed via in person meeting and Google Forms through email and Zoom; data collected over two weeks.
  • Analysis: Quantitative analysis using mean, standard deviation, and median (IQR) to rank-order the significance of factors for each group.
  • Ethics: Deemed IRB exempt as it involved educational surveys without direct patient interaction.

Methods

  • Response Rates: High engagement across all groups: Investigators (100%), Research Staff (100%), and CAB (95%).
  • Logistical Factors: Consistently ranked high by all groups (means between 4.0 and 4.3). Research staff identified these as the primary concern.
  • Information vs. Culture: Investigators and Research Staff rated Cultural and Community factors more highly, whereas the CAB placed a higher priority on Information and Engagement (e.g., knowledge of the drug/condition).
  • Commonalities: All groups ranked childcare as one of the least important factors affecting recruitment.
  • CAB Priorities: Uniquely emphasized reliable transportation (ride-sharing/public transit) and informed decision-making through education.

Results

References

1. Castellon-Lopez Y, et al. Community engagement and minority enrollment in COVID-19 vaccine trials. [Journal Info].

2. NIH Revitalization Act of 1993, Pub. L. No. 103-43.

3. Food and Drug Administration. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. 2022.

4. Clark LT, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol.

Acknowledgements

Thank you to Winn CIPP, UCLA Harbor, and OUWB SoM Embark.

Addressing diversity in clinical trials requires a multifaceted approach tailored to specific stakeholder insights. While investigators focus on cultural competence, the community (CAB) prioritizes tangible logistics (transportation) and clear information. The success of the COVID-19 trials at Lundquist suggests that involving community representatives early in the recruitment process is vital for bridging the gap between research teams and local minority populations.

Conclusions