Clinical Trials

Clinical trials and health research represent important scientific endeavors designed to provide bases for understanding human biology and health, for preventing disease, for testing new medical technologies and treatments, and for enhancing quality of life. Despite the potential benefits of clinical trials and health-related research, rates of participation are generally low, hovering around 3%. Participation is especially low among racial/ethnic minorities, medically underserved populations, and older persons. Increasing the participation of racial/ethnic minorities in health research has emerged as a major issue for scientists over the past two decades given the National Institutes of Health (NIH) Revitalization Act of 1993. Accordingly, it is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human participants unless a clear and compelling rationale is presented. Additional impetus is given to the need to have minorities participate in health research because of their higher morbidity and mortality across many diseases and conditions. For example, the health disparities between African Americans and Whites are well documented with regard to higher rates of diabetes, hypertension, cardiovascular disease, stroke, and other conditions for African Americans. Similarly, health disparities are documented for Hispanic sub-populations and some Asian groups. To eliminate these disparities and to develop appropriate interventions and treatments that will work best for minorities, it is essential that they be participants in clinical trials and health-related research. Moreover, they need to participate in sufficient numbers for meaningful analyses.

In addressing the need to understand how to increase the participation of minorities, a growing [Page 110]body of literature has examined recruitment barriers and strategies and also has refined concepts and approaches to the issue. For example, it is important to consider how the different types of studies, from behavioral to clinical, affect the willingness of minorities to participate in health-related studies. Research on recruitment has distinguished between clinical treatment trials that are offered to individuals with illness symptomatology as opposed to prevention, behavioral and nontherapeutic kinds of studies often conducted on healthy populations. Clearly, willingness to participate in health-related research such as clinical treatment trials may be motivated by the presence or absence of illness or disease. In addition, participation may be affected by the degree of participant burden as well as by the incentives that are offered.

Among the barriers to minority participation in health research are experiences of past discrimination that are associated with lower levels of trust in the health care system and scientific research. Prior studies indicate that African Americans are more likely than Whites to be concerned about being exploited, being treated as a “guinea pig,” and being treated dishonestly regarding the risks of research participation. Studies also show that minorities are less likely to be aware of clinical trials and may also be less likely to be offered clinical trials by their physicians. In addition, socioeconomic factors may impede participation in health research because significant numbers of minorities have low incomes and lack access to consistent primary care and, accordingly, to clinical trials. Other barriers include cultural factors related to language and health beliefs as well as low literacy that can impede communication between research staff and prospective participants. Additional barriers stem from medical ineligibility to participate and instrumental concerns such as lack of child care, lack of access to transportation, lack of release time from work, and lack of geographic proximity to research sites.

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