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The committee finds that overall, the level of accrual of ethnic minorities in NCI-sponsored treatment trials is proportionate to the disease burden among these populations, with a few exceptions for specific cancer sites. NCI-sponsored prevention trials, however, suffer from poor accrual of ethnic minorities. The recently concluded trials of the chemopreventive agent tamoxifen, for example, demonstrated that the drug successfully prevented breast cancers in thousands of women at high risk for the disease. Only 2 percent of the overall study sample, however, were African American, and even smaller percentages of individuals from other ethnic groups were entered into this study. Such poor accrual raises significant questions regarding the generality of these findings to the total U.S. population.
Many factors may affect researchers' ability to recruit ethnic minority and medically underserved populations into prevention trials. One of the most significant challenges lies in the lack of funding for associated follow-up costs. In cancer screening trials, for example, NIH in most instances does not provide funding to cover costs of care for indigent populations with positive test results (Peter Greenwald, acting director, Division of Cancer Prevention, National Cancer Institute, presentation to the study committee, June 12, 1998). The committee considers the federal government's failure to provide follow-up care to needy, uninsured patients to be unethical and urges greater coordination among federal agencies to address the problem.
Another factor that may limit the participation of ethnic minority and medically underserved populations in clinical trial research is the complexity of the informed-consent process. Informed consent is the first step in establishing a bond of trust between researchers and research subjects; yet too often informed-consent forms are long, technical, difficult to administer, and not well understood by patients. The committee urges NIH to work with other agencies to explore alternative means of obtaining patient consent (e.g., oral consent) that respect patient autonomy and that do not compromise the informed-consent process.
NCI has developed several sophisticated mechanisms for the dissemination of information to cancer patients, clinicians, and others. Much of this effort has been guided by consumer research and an effective marketing plan. Relatively little attention, however, has been devoted to the specific needs of ethnic minority and medically underserved populations. Despite the presence of cancer information materials that have been translated into Spanish and other products targeted to ethnic minority communities, no strategic plan regarding information dissemination to these groups and their health providers appears to exist. Furthermore, the committee did not find evidence of any evaluations of the effectiveness of dissemination practices in ethnic minority and medically underserved communities. Such efforts are necessary to ensure that individuals in these