African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender
Introduction
The Randomized Clinical Trial (RCT) is one of the most effective methods for evaluating the efficacy and safety of healthcare interventions [1]. However, low participation rates and under-representation of racial/ethnic and other minorities in clinical trials and in the published literature may be insufficient to accurately assess the safety and efficacy of many new health care treatments among racial/ethnic and other minorities [2], [3], [4], [5], [6]. The purpose of the present study was to explore African Americans' attitudes regarding clinical research by gender in order to identify possible strategies to improve participation.
Non-participation of racial/ethnic minorities in clinical research and clinical trials jeopardizes the generalizability of findings, limits ability to do subgroup analysis, denies patients access to state-of-the-art treatment for disease, and raises issues about equity in health [7], [8]. Under-representation is especially deleterious for diseases that have disparities in health outcomes by race and ethnicity. The National Institutes of Health Revitalization Act 1993 mandates broader inclusion of minorities in clinical research and clinical trials [9]. Although federal initiatives mandate inclusion of minority groups in research that inclusion has not consistently translated to reporting of results that might guide therapeutic decisions [2], [9], [10]. Although, more attention has been paid to this problem, there is still a need for significant strides to advance empirical evidence that explains under-representation of racial/ethnic minorities in clinical trials. Recent groundbreaking research led by investigators at the National Institutes of Health (NIH) has shattered the myth that racial/ethnic minorities are generally less willing than non-Hispanic whites to participate in health research [2]. In fact, the authors cited several studies in which minorities agreed to participate at significantly higher rates than non-Hispanic whites suggesting that there are other important issues affecting minority participation in clinical research. One of the limitations cited in the NIH study was not assessing minority groups' attitudes toward health research.
Historically, women have been under-represented in clinical research [11]. Data on under-representation of minorities in clinical research by gender is limited. Some research studies on participation and retention in clinical trials indicate that recruiting sufficient numbers of women, especially minority women, is often challenging [11], [12], [13], [14], [15], [16], [17], [18]. For example, a cancer clinical trial found that black women were less likely than white women to participate as a result of “more negative attitudes toward clinical trials” [15]. Under-representation of women in clinical trials has similar implications to low minority participation, including fewer opportunities for the patient to receive state of the art treatments and limited ability to generalize and develop treatments for women. Studies that explore how both gender and race/ethnicity influence participation are clearly needed.
Motivators to encourage research participation for minorities are not well investigated. More research is needed regarding procedures and methods that can be employed that may encourage racial/ethnic minority group participation. Strategies to increase participation have included culturally and contextually sensitive strategies to overcome barriers to minority participation [19]. Building trust during the research process, explaining clearly the participation criteria, risks and benefits of participation, and including African Americans in the study design from project inception to data analysis and presentation, have been found to be critical components in obtaining African American participation in planning research studies [19], [20]. Careful attention also needs to be given to study design inclusion and exclusion criteria. Many minorities are excluded from study participation on the basis of poor health status and presence of comorbid illness [21]. Given the evidence that both racial/ethnic minorities and women, especially minority women are often difficult to recruit into clinical trials, it is possible that recruitment strategies need to be tailored by race and gender, not just one or the other.
Section snippets
Study design
A qualitative focus group study of African Americans was conducted to explore gender differences in perceptions of 1) barriers and motivators to participation in clinical trials and perceived need of clinical trials, and 2) perceptions of risks and benefits of African American participation in clinical trials.
Focus group methodology has proven to be effective in uncovering beliefs, perceptions, opinions and attitudes about health services, prevention, and treatments in minorities [22], [23],
Men
The mean age for male participants was 32.3 (ranging from 19–60). Fifty percent of male participants had completed high school, 38% completed college and 12% completed an advanced degree. Sixty-eight percent of male participants were employed, 25% were students (undergraduate or graduate) and 6% were retired.
Women
The mean age for female participants was 42.7 (ranging from 19–65). Forty-nine percent of female participants had completed high school, 34% completed college and 17% completed an advanced
Discussion
A low rate of minority participation in clinical trials is a long-standing problem. It has a direct impact on public health and the elimination of health disparities. Identifying methods to market clinical trials as a “win win” paradigm, increasing minority investigator participation in research and improving the researcher–participant relationship are ongoing challenges to increase minority participation. These issues need to be tackled on a community-by-community basis. Although the issues of
Recommendations
The current literature suggests that the strategies to improve minorities' participation in clinical trials must include: 1) effective communication and interaction between the clinical trials team and the minority community [31], 2) building trust by developing culturally sensitive research teams [32], [33], 3) planning to eliminate the burden of cost such as, transportation, childcare, and time off from work as reasons for minorities not participating in clinical trials [9], [34].
Results from
Acknowledgements
This study was supported by three funding resources from NIH, RCMI-TRANSLATIONAL RESEARCH NETWORK (RTRN) Grant (# NIH- RR11145), Charles R. Drew University of Medicine and Science, and in part by the Meharry Clinical Research Center Grant (#P20RR011792) from NIH and RCMI Clinical Infrastructure Initiative. The project described was also partially supported by NIH Grant Number 5 P20 MD000516-03 from the National Center on Minority Health and Health Disparities. Its contents are solely the
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