Willingness to Participate in Clinical Trials among African Americans and Whites Previously Exposed to Clinical Research

By Durant, Raegan W.; Legedza, Anna T. et al. | Journal of Cultural Diversity, Spring 2011 | Go to article overview

Willingness to Participate in Clinical Trials among African Americans and Whites Previously Exposed to Clinical Research


Durant, Raegan W., Legedza, Anna T., Marcantonio, Edward R., Freeman, Marcie B., Landon, Bruce E., Journal of Cultural Diversity


Abstract: The objective of this study was to identify racial differences in willingness to participate in a population with previous exposure to clinical research. A survey instrument was administered to community-dwelling whites and African Americans who were voluntarily receiving a lay research and health education newsletter from a local Boston geriatric clinical research institution. The survey instrument assessed willingness to participate in 3 hypothetical clinical trials (diet trial for obesity, medication trial for hypertension [HTN], chemotherapy trial for cancer). Surveys were received from 473 whites and 279 African Americans (53% response rate) with mean age 74 (SD ± 9). In multivariate models, race was not significantly related to willingness to participate in the multivariate models for any of the 3 trials. Previous trial participation was related to a higher odds of willingness to participate in the diet trial only (OR 1.8, 95% CI 1.2,2.6). Lower levels of trust in one's primary care physician were associated with a lower odds of willingness to participate in clinical trials for the diet and HTN trials (OR 0.5, 95% CI 0.3,0.8 and OR 0.6, 95% CI 0.3,0.9, respectively). These findings suggest that, within populations previously exposed to clinical research, African Americans are no less willing to participate in clinical trials compared to whites.

Key Words: Minorities, Clinical Trials, Patient Selection

Despite National Institutes of Health (NIH) mandates in 1993 for the inclusion of racial and ethnic minorities in clinical trials, African Americans and other minority groups continue to be underrepresented in clinical trials. Minority underrepresentation raises concerns that trial results will lack generalizability to these populations (Freedman et al., 1995; NIH, 2001). Previous studies have suggested that lower enrollment in trials among African Americans may be due to a lower willingness to participate (Baquet, Commiskey, Daniel Mullins, & Mishra, 2006; Braunstein, Sherber, Schulman, Ding, & Powe, 2008; Brown & Topcu, 2003; Buchbinder et al., 2004; V. L. Shavers, Lynch, & Burmeister, 2002; Stone, Mauch, Steger, Janas, & Craven, 1997; Unson et al., 2004).

Racial differences in personal preferences for participation may be attributable to multiple factors including socioeconomic status, logistical barriers and concerns about a lack of personalbenefit (Comis, Miller, Aldige, Krebs, & Stoval, 2003; Roberson, 1994; Ross et al., 1999; Swanson & Ward, 1995). However, distrust in clinical research is the most commonly cited contributor to a lower willingness to participate among African Americans (Braunstein et al., 2008; Buchbinder et al., 2004; el-Sadr & Capps, 1992; Yancey, Ortega, & Kumanyika, 2006). In a study of African Americans and whites receiving care at 13 different primary care and cardiology clinics, investigators found that racial differences in willingness to participate were most attributable to higher levels of distrust in clinical research among African Americans, even when taking into account other factors such as socioeconomic status and access to care (Braunstein et al., 2008). This distrust in clinical research among African Americans is thought to stem from the legacy of the U.S. Public Health Service Tuskegee Syphilis Study and other past research abuses (Corbie-Smith, Thomas, Williams, & Moody-Ayers, 1999; Smith et al., 2007). Potential study participants are often referred through the health care system because of easy access and a presumption of some familiarity with the health care enterprise (UyBico, Pavel, & Gross, 2007). Yet, racial differences in distrust and willingness to participate can be observed even in those populations that are actively engaged in the health care system (Braunstein et al., 2008; Creel et al., 2005; Stone et al., 1997).

Less is known about racial differences in willingness to participate among persons who have been exposed to clinical research in some manner.

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