Lack of Diversity in Clinical Studies Limits Potential Relevance for Medically Underserved Patients
Minorities and residents of some rural areas in Maryland are participating at lower than expected rates in federally funded cancer treatment clinical trials, which may suggest growing racial, ethnic and geographic disparities in cancer treatment.
That’s according to a new study led by Claudia R. Baquet, M.D., M.P.H., a professor of medicine and associate dean for policy and planning at the University of Maryland School of Medicine and director of the school’s Center for Health Disparities Research and Outreach.
The study which looked at 2,240 Maryland cancer patients enrolled in National Cancer Institute (NCI)-sponsored clinical trials from 1999 to 2002, will be published in the July 10, 2008, issue of the Journal of Clinical Oncology. Dr. Baquet’s co-authors are Gary L. Ellison, Ph.D., M.P.H., an epidemiologist in the Office of Policy and Planning and an instructor of the School of Medicine, and Shiraz I. Mishra M.B.B.S., Ph.D., an associate professor of the School of Medicine and deputy director for evaluation and outcomes in the Office of Policy and Planning.
The percentage of Maryland patients participating in NCI-funded cancer treatment clinical trials rose one percent over the four-year period, to 2.9 percent in 2002, but the percentage of African-American participants fell an estimated 8.9 percent per year, according to the study.
“Low representation of African-Americans, other minorities and rural patients in cancer clinical trials could contribute to health disparities. Without adequate diversity, it may be difficult to generalize about trial results because you don’t know whether new treatments or preventive strategies have comparable effects among patients from diverse racial or ethnic groups,” Dr. Baquet explains.
The study’s results are particularly significant because the African-American community shows disproportionately high rates for certain cancers, according to Dr. Baquet. These include colon cancer, aggressive forms of breast cancer and prostate cancer.
This is the first study to focus on Maryland’s patient participation rates in cancer treatment clinical trials funded by the NCI, which is part of the National Institutes of Health. It looked at clinical trials funded by NCI’s Clinical Trials Cooperative Group Program, which are offered at cancer centers, community hospitals and oncology practices. The study did not include NCI-sponsored treatment trials initiated by individual investigators or those funded by private industry.
Other findings of the study, which was funded by the NCI and the NIH National Center for Minority Health and Health Disparities, include:
Dr. Baquet notes that the University of Maryland School of Medicine’s Center for Health Disparities Research and Outreach has developed intensive, multilevel programs to help increase minority and rural participation in clinical trials on Maryland’s Eastern Shore.
The Center for Health Disparities Research and Outreach at the School of Medicine, funded by NIH’s National Center for Minority Health and Health Disparities, strives to help close the health care gaps between the races. Its Maryland Community Cancer Clinical Trial Program on the Eastern Shore of Maryland works to get minorities and residents of rural areas more involved in clinical trials.
“This program is part of the center’s efforts, in partnership with Dr. Mary DeShields at the Eastern Shore Cancer Research Network, to increase diversity in clinical trials, cancer clinical trials in particular,” Dr. Baquet says.
“We will continue to monitor cancer patients’ participation in clinical trials in Maryland, expand our community-based clinical trials educational efforts and provide continuing education for physicians and other health care professionals providing care to African-American, rural and other underserved communities,” she says.
In 2004, Drs. Baquet and DeShields received the first and only National Best Practice Award from the U.S. Department of Health and Human Services for increasing rural cancer patient participation in clinical trials on the Eastern Shore.
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