screening studies, such as the PLCO study, are constrained by the U.S. Office of Management and Budget mandate that a collaborating site must have adequate numbers of patients with all four diseases included as part of the PLCO study. This eliminates centers such as the Veterans Affairs Hospital system as a potential partner, despite the large numbers of people eligible for the prostate, lung, and colon cancer part of the study.
These barriers point to the need for NIH-supported researchers to form partnerships with community-based health service providers and community leaders. In an extensive review of the literature regarding recruitment of ethnic minorities into clinical trials, Swanson and Ward (1995) emphasize the need for researchers to develop community networks, provide community outreach services and programs, establish bonds with community leaders, and recruit as investigators ethnic minority physicians and other health service providers who serve primarily an ethnic minority clientele. Involving community members early in research design and implementation plans can also yield benefits for subject recruitment, as well as for ensuring the smooth operation of a study. Some researchers, for example, have enlisted the cooperation of churches and pastors in African American communities to overcome suspicion of research goals, generate referrals, train lay health workers, and generally promote awareness of healthy behavior. Swanson and Ward, however, note that "contrary to pervasive beliefs about this approach, it is not a panacea for achieving high participation rates of African Americans in clinical trials" (Swanson and Ward, 1995, p. 1753). Multiple approaches and strategies are necessary, they note, to ensure the "buy-in" of community members.
Community-based health care providers and community health clinics, such as the federally supported Community Health Centers (CHCs), offer great potential to researchers as sites to recruit patients and health care providers, to bridge cultural and linguistic gaps between researchers and target populations, and to train new researchers. CHCs serve as primary care providers for more than 9 million low-income patients, many of whom are ethnic minority. NCI support for training, research, and data collection in these settings should be explored not only as a means of increasing the accrual of ethnic minority and medically underserved populations in clinical trials, but also as a point of information dissemination regarding cancer prevention and treatment.
Finally, greater education of researchers is an important component of an overall strategy to improve the rate of recruitment of ethnic minority and medically underserved individuals into clinical trials. Some researchers may not be aware of the importance, from scientific and ethical perspectives, of demographically diverse subject pools; others may reject such goals as "political" or "inconvenient." However, anticipation of when interventions are expected to affect subpopulations differently is critically important.