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Background <p>Patient diversity in clinical trials has been a critical issue in the advancement of translational scientific research. There is a dire need for better representation of all populations to understand the efficacy of novel therapeutics and health interventions for promising outcomes. The current study aims to identify key factors that may lead to equitable participation in clinical research.</p> Methods <p>This qualitative study included focus groups with lower-income, racially or ethnically diverse community members (<i>n</i> = 51) and research stakeholders (<i>n</i> = 50) to identify factors that influence clinical trial participation. Focus groups were conducted between November 2023 and May 2024 within community-settings in Dallas, Texas. Directed Content Analysis using the Socioecological Model (SEM) as the theoretical framework was utilized for data analysis.</p> Results <p>Key barriers, facilitators, and implementation strategies to clinical trial participation across four levels – individual, interpersonal, community, and macroeconomic/policy – were identified from the perspectives of community members and research stakeholders, separately. Prominent barriers included fear and mistrust at the individual level; misconceptions at the interpersonal level; historical experiences (defined as collective mistreatment faced by the participant’s community), lack of knowledge, and logistics at the community level; systemic mistrust as well as racism and consent/study language at the macroeconomic/policy level. Facilitators included personal health knowledge, monetary incentives, and safety at the individual level; trusted relationships and family health knowledge at the interpersonal level; altruism at the community level; transparency of safety/risk at the macroeconomic/policy level. Implementation strategies proposed were rebuilding trust, building relationships through community engagement, increasing awareness about clinical research, and leveraging culturally tailored resources to promote inclusiveness.</p> Conclusions <p>Underrepresentation of diverse populations in clinical studies warrants the need to consider multifaceted approaches to mitigate the current public health crisis. Ultimately, building trust, community engagement to promote knowledge and awareness, and transparency are essential for improving diversity in clinical trials.</p>

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Mapping the path to diversity in clinical trials: a qualitative study of community member and stakeholder perspectives

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月9日

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  • Meera J. Patel,
  • Ketan Tamirisa,
  • Emilie Ruiz,
  • Zahria Griggs,
  • Eunice Huan,
  • Heather Kitzman

摘要

Background

Patient diversity in clinical trials has been a critical issue in the advancement of translational scientific research. There is a dire need for better representation of all populations to understand the efficacy of novel therapeutics and health interventions for promising outcomes. The current study aims to identify key factors that may lead to equitable participation in clinical research.

Methods

This qualitative study included focus groups with lower-income, racially or ethnically diverse community members (n = 51) and research stakeholders (n = 50) to identify factors that influence clinical trial participation. Focus groups were conducted between November 2023 and May 2024 within community-settings in Dallas, Texas. Directed Content Analysis using the Socioecological Model (SEM) as the theoretical framework was utilized for data analysis.

Results

Key barriers, facilitators, and implementation strategies to clinical trial participation across four levels – individual, interpersonal, community, and macroeconomic/policy – were identified from the perspectives of community members and research stakeholders, separately. Prominent barriers included fear and mistrust at the individual level; misconceptions at the interpersonal level; historical experiences (defined as collective mistreatment faced by the participant’s community), lack of knowledge, and logistics at the community level; systemic mistrust as well as racism and consent/study language at the macroeconomic/policy level. Facilitators included personal health knowledge, monetary incentives, and safety at the individual level; trusted relationships and family health knowledge at the interpersonal level; altruism at the community level; transparency of safety/risk at the macroeconomic/policy level. Implementation strategies proposed were rebuilding trust, building relationships through community engagement, increasing awareness about clinical research, and leveraging culturally tailored resources to promote inclusiveness.

Conclusions

Underrepresentation of diverse populations in clinical studies warrants the need to consider multifaceted approaches to mitigate the current public health crisis. Ultimately, building trust, community engagement to promote knowledge and awareness, and transparency are essential for improving diversity in clinical trials.