April 11, 2014

Two studies led by UAB examine minority participation in cancer clinical trials
The research was conducted as part of a consortium of five institutions called EMPaCT, Enhancing Minority Participation in Clinical Trials.

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Twenty years after the 1993 National Institutes of Health Revitalization Act established guidelines for the inclusion of minorities in clinical trials, there still are gaping health disparities in minority enrollment—less than 5 percent of clinical trial patients are non-white and 2 percent of cancer clinical trials focus on non-white racial groups.

Two studies published in the March supplement of Cancer led by researchers at the University of Alabama at Birmingham School of Medicine examined factors likely to contribute to minority patients’ adherence to clinical trial protocols and ways to address barriers faced by cancer centers in recruiting minority study participants.

Durant RaeganRaegan Durant, M.D., MPHThe research was conducted as part of a consortium of five institutions — UAB, the University of Minnesota, Johns Hopkins University, MD Anderson Cancer Center and the University of California, Davis — called EMPaCT, Enhancing Minority Participation in Clinical Trials.

“Because access to cutting-edge medical treatments and state-of-the-art care provided by clinical trials is not equally available to individuals in minority communities, an inequity in participation contributes to ongoing health disparities,” says Selwyn M. Vickers, M.D., senior vice president for medicine at UAB and dean of the School of Medicine. Vickers is co-principal investigator of the EMPaCT grant from the National Institute on Minority Health and Health Disparities, a part of the National Institutes of Health.

The first study, led jointly by Raegan Durant, M.D., MPH and Michelle Martin, Ph.D., both assistant professors in UAB’s Division of Preventive Medicine, used 91 interviews of cancer center administrators, principal investigators, research staff and referring clinicians from the five EMPaCT institutions to identify key themes related to barriers and facilitators of minority recruitment.

The research showed that enrollment facilitators could enhance recruitment by making key relationships with community stakeholders, and that more standardization of external clinical trial referral procedures could lead to the recruitment of minority patients who are not already being treated at a cancer center, Durant says.

Minority patients are influenced by skepticism of clinical research, Durant says, but there are nuances to skepticism that have been previously overlooked. Many studies show the key component of that skepticism is distrust, stemming from the legacy of discrimination and frank abuse in research trials like the federal government’s 40-year U.S. Public Health Service Syphilis Study at Tuskegee,” Durant says.

 “While distrust may be one example of skepticism, our interviews found distaste for medical experiments or inherent uncertainty in clinical trials, for instance not knowing which group they’re in during a blind trial, can make some people reticent to participate,” Durant says.

Another major theme is that minority patients often face barriers to access clinical trials from the participant and system levels. A wide spectrum of inhibiting factors includes a lack of family support, unmet transportation needs, competing work or dependent care responsibilities, stringent inclusion and exclusion criteria and inadequate means of enrolling uninsured patients.

 “These multi-level barriers often keep some minorities from being offered opportunities to participate,” Durant says. “It’s not that they were refusing research trials or getting into trials and dropping out, but that they didn’t get to the point of being offered the opportunity to enroll because of the barriers they face.”

The second UAB-led study examined personal-level barriers facing young, low-income African-American women by paring trained community health advisors with a group of women participating in the Atypical Squamous Cells of Undetermined Significance–Low-Grade Squamous Intraepithelial Lesion Triage Study, known as ALTS, a multicenter clinical trial evaluating optimal clinical management of low-grade abnormal pap smear tests. One of the test sites was UAB, with women enrolled in the trial from the Jefferson County Health Department.

The CHAs,  identified as “natural leaders” in communities where ALTS trial patients lived in Jefferson County, provided intervention and assistance in keeping patients on track with their participation, on top of retention incentives provided for all trial participants, including reminder cards and calls from nurses and cash at each visit.

Mona-FouadMona Fouad, M.D., MPHResults showed a significant difference in trial protocol adherence and retention, indicating that CHAs could be valuable partners in clinical trials, says Mona Fouad, M.D., MPH, senior associate dean for Diversity and Inclusion and director of the Division of Preventive Medicine and the UAB Minority Health and Health Disparities Research Center.

“The trial participants were more open with the Community Health Advisors in expressing their issues because they knew the CHAs understood their lifestyle and priorities because they’re from the same communities,” Fouad says. “The CHAs were able to mentor and assist the patients in overcoming some of their obstacles—embarrassment in not understanding medical terms, difficulty arranging child care or transportation and addressing family skepticism of clinical research– making it easier for the young women to stay enrolled in the trial.”

Health disparities or gaps in quality of health and health care, in the U.S. are well-documented in African-Americans, Native Americans, Asian American and Latinos. Compared with whites, these groups experience higher incidences of heart disease, stroke, diabetes, cancer and other chronic diseases; higher mortality from these diseases and poorer health outcomes.

Fouad says the increased focus on personalized medicine is another key reason to continue advocating for minority recruitment in clinical studies.

“Personalized medicine is supposed to be targeting medical treatments on the individual level. If we don’t include African-Americans and other minorities in clinical trials, the gap in health care is going to get event wider,” Fouad says.
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