Clinical Research Trials: Factors That Influence and Hinder Participation

By Kennedy, Betty M.; Burnett, Michael F. | Journal of Cultural Diversity, Fall 2007 | Go to article overview

Clinical Research Trials: Factors That Influence and Hinder Participation


Kennedy, Betty M., Burnett, Michael F., Journal of Cultural Diversity


Abstract: The objective of this study was to examine factors that influence and hinder participation of African Americans in clinical research trials. Specifically, we examined and compared the perceived advantages and disadvantages to participation in clinical research trials, exposure to selected experiences prior to participation (i.e., who and what influenced the decision to participate or not), and perceptions regarding necessary preparation for participation in clinical research trials. Three hundred eighty six African Americans responded to the questionnaire that was administered in the study. As expected, African Americans who had previously participated in a clinical research trial agreed with factors perceived as advantages to participation, while respondents who had not previously participated endorsed factors perceived as potential disadvantages to participation in clinical research trials.

Key Words: African Americans, Clinical Trials, Barriers, Motivators, Recruitment Strategies

Previous abusive clinical research trials have resulted in several obstacles that continue to hinder the successful recruitment of African Americans into clinical trials today. Past experiences, including studies without written protocols or informed consent, have left doubt, fear, and mistrust among African Americans. Modern clinical research trials are designed and monitored to safeguard against this type of abuse; however, the past effects of government-sponsored racism do not dissipate quickly (Shavers, Lynch, & Burmeister, 2000; Thomas, Pinto, Roach, & Vaughn, 1994).

One major incidence experienced in the past by African Americans was the Tuskegee Study of Untreated Syphilis. This study involved over 400 African American farmers and was conducted by the United States Public Health Service from 1932 until 1972 (Jones, 1993). In this study, African American men with a diagnosis of syphilis were given no specific antisyphilitic treatment for 40 years in order to observe the natural history of this infectious disease in a large cohort (Thomas et al., 1994). Although this study concluded approximately 35 years ago, it is still very prevalent in the minds of African Americans today (Bates & Harris, 2004; McCallum, Arekere, Green, Katz, & Rivers, 2006).

Despite the Tuskegee Study and other abusive studies in the past, participation in clinical research may be beneficial. For example, participation in clinical trials research can potentially ease the cost burden of traditional medical treatment for individuals who are at risk for high blood pressure, high cholesterol, heart disease, cancer, Type II diabetes, and obesity. African Americans and other ethnic minority populations in the United States are disproportionately affected by these chronic diseases (Singh, Kochanek, & MacDorman, 1996; Smedley, Stith, & Nelson, 2003). Nonparticipation of racial and ethnic minorities in clinical research and clinical trials jeopardizes generalizability of findings, limits ability to conduct subgroup analysis, denies patients access to state-of-the-art treatment for disease, and raises issues about equity in health (Giuliano et al., 2000; Heiat, Gross, & Krumholz, 2002). Therefore, to reduce disparities in health status related to race and/or cost, it is necessary for both parties who are responsible for the funding and the conduct of clinical research to understand African Americans' perception of clinical research trials.

The objective of this study was to examine factors that influence and hinder participation of African Americans in clinical trials research. Specifically, we examined and compared the perceived advantages and disadvantages of participation in clinical research trials, exposure to selected experiences prior to participation (i.e., who and what influenced the decision to participate or not), and perceptions of African Americans regarding necessary preparation for participation in clinical research trials. …

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Clinical Research Trials: Factors That Influence and Hinder Participation
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