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1.5 Inclusion of Diverse Participants in Clinical Research

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The inclusion of diverse participants in clinical studies is related to minority health research but is a distinct topic. The inclusion of women, children, and minorities in clinical research was mandated by Congress in 1993.5 Although significant progress has been made in engaging women as participants in clinical research, participation from racial/ethnic minority groups remains low. Every clinical study cannot be powered to stratify outcomes by race/ethnicity, but when the data indicate a significant disparity in rates or outcomes, there is a scientific responsibility to address diversity.

One example where this was prospectively addressed is the Diabetes Prevention Trial that evaluated results by race/ethnicity [18]. The lack of diverse genotype data on minority populations in the United States has been highlighted [19], and the randomized trials evaluating efficacy of prostate cancer screening, for example, have had limited minority participation despite the fact that prostate cancer is two to three times more common among African Americans [20–22]. Future clinical research needs to ascertain greater granularity of social and demographic determinants in addition to age, gender, and race/ethnicity, such as SES, birthplace, language proficiency, sexual orientation/gender identity, and geographic residence.

Many investigators find it challenging to recruit minorities to participate in clinical studies. Successful recruitment may require different strategies, more resources, and, frequently, unfamiliar skills. Research indicates that recruitment of minorities may be more successful when active strategies (e.g., more in‐person contact, personalized messages, and active outreach) are used rather than passive strategies (e.g., mass mailings, advertisements), which are the norm for many studies [23]. Further research is needed to understand the best mechanisms to recruit and retain minority and other health disparity populations in clinical research, especially clinical trials to identify the most appropriate prevention, detection, and treatment strategies for everyone. Given that minorities constitute close to 40% of the US population, diversity of participants in clinical studies is not merely a legal mandate but critical to the conduct of ethical, equitable, and rigorous science.

The Science of Health Disparities Research

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