Gaps in clinical trial diversity remain in spite of efforts to raise awareness, encourage participation


COLUMBUS, Ohio – Despite minority patients reporting high levels of trust in their health care providers, more work needs to be done to increase the number of patients from racial and ethnic minority populations that participate in clinical trials, according to a new study from The Ohio State University College of Medicine.

The research, published in the Journal of General Internal Medicine, looked at the connection between race and ethnicity and clinical trial invitation, participation and knowledge. It also examined the sources of influence on whether to join a clinical trial.

“Clinical trial diversity is critical for the development of safe, effective therapies and interventions to advance health equity,” said Daniel Walker, associate professor in the Department of Family and Community Medicine and member of the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research. “Recent efforts to increase clinical trial awareness and reduce racial and ethnic disparities in participation have yet to move the needle as non-Hispanic white populations continue to be the highest participants in clinical trials. This study seeks to understand why.”

According to the U.S. Census Bureau, racial and ethnic minority groups comprise 40% of the U.S. population. In contrast, the U.S. Food and Drug Administration reports 75% of the 32,000 patients that participated in clinical trials which evaluated 53 novel drugs in 2020 were non-Hispanic white.

To explore this disparity, researchers examined the results of the Health Information National Trends Survey (HINTS) that took place from February – June 2020. HINTS collected data from adults in the U.S. regarding health care utilization, health information technology use and demographics. In total, 3,865 adults 18 years of age and older participated. The survey respondents self-reported race and ethnicity categories were non-Hispanic white, non-Hispanic Black, Hispanic and non-Hispanic other. 

Researchers analyzed the data and found:

  • Non-Hispanic Black participants had higher odds of being invited into a clinical trial but no differences in odds of participation were observed by race and ethnicity.
  • All survey participants, regardless of racial and ethnic background, said their personal health care providers were the most trusted source of clinical trial information, followed by health organizations and government health agencies.
  • Hispanic, non-Hispanic Black and non-Hispanic other participants had lower odds than non-Hispanic white participants of saying they would be influenced a lot by their doctor encouraging participation.
  • Non-Hispanic Black participants had lower odds than non-Hispanic white participants of indicating family encouragement would influence their clinical trial participation decision a lot.

“Our findings indicate mistrust in the medical system may play a larger role than trust in one’s personal health care providers when it comes to influencing racial and ethnic minority patient participation in clinical trials,” said Dr. Joshua J. Joseph, assistant professor in the Department of Internal Medicine at Ohio State College of Medicine and endocrinologist at The Ohio State University Wexner Medical Center.

The paper recommends future efforts to improve clinical trial diversity should reach outside of health care systems to build trust directly in communities. Researchers in academia, government and industry should leverage the established relationships community organizations have with racial and ethnic populations to develop community-informed, community-engaged and community-based participatory research approaches to increase diversity.

Study co-authors include: Christine M. Swoboda, Karen Shiu-Yee, Willi L. Tarver and Timiya S. Nolan.

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Media Contact: Serena Smith, Wexner Medical Center Media Relations, Serena.Smith@osumc.edu

 



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