Racial minority participation in clinical trials increase with information and access

December 12, 2005

Racial minorities participate in health research studies at the same rate as whites when they meet the study criteria and when they are informed about the opportunity to enroll in the study, according to an article by researchers at the National Institutes of Health (NIH) and Yale School of Medicine.

Published in the December 6 PLoS Medicine, the study debunks the common belief that racial minorities are less willing to participate in research studies, and the authors suggest that minority involvement is linked more to access than attitude.

"It's been known for years that black patients are less likely to enroll in research studies than white patients," said a study author, Cary Gross, M.D., associate professor of internal medicine at Yale. "This is a problem because research studies are how we determine which new treatments are effective and which ones shouldn't be used. If the participants in these studies do not reflect the diverse nature of the population, then it won't be clear whether new treatments that may have been promising in the study setting actually work in the real world."

According to lead author Ezekiel Emanuel, M.D., chair of the Department of Clinical Bioethics at NIH, there is a belief that racial and ethnic minorities are less willing to participate in health research due to a distrust of the research community stemming from past abuses. The most notable is the Tuskegee syphilis study, in which hundreds of poor African American men in Alabama were followed for decades without being told they had syphilis, promised treatments and prevented from getting penicillin to treat their syphilis.

The study found that whatever attitudes blacks and other ethnic minorities may have, they are still willing to participate in research when there is an opportunity to do so. The authors say that the main barrier to participation is access, knowledge that these studies exist, eligibility criteria that ensure minorities can participate, and overcoming existing logistical barriers such as the need for child care, the location of the study and reimbursement for travel expenses.

The research team comprehensively searched the medical literature to identify published trials that reported consent rates by race and/or ethnicity. The team identified and reviewed 20 different kinds of studies involving over 70,000 patients. Most were conducted in the United States and most participants from minority groups were African Americans or Hispanics.

The researchers found only small differences in the willingness of minorities to participate compared to non-Hispanic whites. But the researchers found big differences when it came to who was asked to participate. In seven of the 17 clinical and surgical intervention studies, enrollment was offered to relatively few people in minority groups.
This study was conducted in collaboration with researchers from the Office of Behavioral and Social Sciences Research at the National Institutes of Health, the Centers for Disease Control and Prevention and Yale University School of Medicine. In addition to Gross and Emanuel, authors included David Wendler, Raynard Kington, Jennifer Madans, Gretchen Van Wye, Heidi Christ-Schmidt, Laura A. Pratt and Otis W. Brawley.

At Yale, contact Cary P. Gross at 203-688-8588 or cary.gross@yale.edu
At NIH contact Ezekiel Emanuel at 301-496-2429 or eemanuel@nih.gov

Citation: PLoS Medicine, (December 6, 2005).

Yale University

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