Improving the Recruitment of Minority Populations in Clinical Trials: Advocating for a Strategic Shift Toward Community-Based Recruitment

Improving the Recruitment of Minority Populations in Clinical Trials: Advocating for a Strategic Shift Toward Community-Based Recruitment

Saliha Akhtar (Seton Hall University, USA) and Michelle Lee D'Abundo (Seton Hall University, USA)
Copyright: © 2017 |Pages: 14
DOI: 10.4018/978-1-5225-1049-9.ch094


Clinical research trials are an important part of establishing evidence-based practice in the U.S. healthcare industry. The purpose of this chapter is to review how the recruitment of minority populations can be improved by creating a strategic shift toward community-based recruitment. The problem of insufficient minority recruitment is defined and contributing factors are reviewed. The relevancy of Lewin's change theory is explained from a staff and organizational perspective. Specific community-based change and leadership strategies that can be applied to clinical research organizations to create a strategic shift to increase minority recruitment are evaluated. Through making minority recruitment a strategic priority, staff and organizations can work with communities to resolve a salient issue in the U.S. healthcare industry.
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As the healthcare industry shifts to a population health approach that focuses more on the prevention of diseases and conditions, healthcare and the delivery of healthcare continues to change rapidly. In addition to the rapidly changing healthcare environment, the demographic composition of the U.S. population continues to diversify. According to the U.S. Census Bureau (2015), minorities represented 37.9% of the U.S. population as of 2014. This number is expected to continue to increase, especially when looking at the representation of minorities within younger generations. For example, in 2014, those younger than five years old became the majority-minority for the first time, representing a whopping 50.2% of the U.S. population (U.S. Census Bureau, 2015). In addition, statistics have shown that the fastest growing population in the U.S. is Asian Americans (Ma et al., 2014b). However, despite this, they are the least represented U.S. ethnic group in clinical trials (Ma et al., 2014b).

Clinical trials must not only keep up with the current trends in U.S. healthcare, but they must also produce evidence that is representative and generalizable to the current population, especially since the need for current trials will continue to increase and expand. As of May 2015, noted having an outstanding 191,938 studies listed across 190 countries (, 2015). Although they may be different in their disease-focus and study design, similar issues are generally experienced. One set of challenges researchers face are those related to participant recruitment. Participant enrollment has proven to be difficult in all disease areas and especially difficult when it comes to the inclusion of minority populations. Researchers have acknowledged this as an ongoing problem with effects seen throughout the clinical trial process and beyond. For example, without sufficient representation of minorities in clinical trials, the effectiveness of those treatments is questioned as it is known that racial and ethnic factors play a role in efficacy (Akhtar, Israel, & D’Abundo, 2015). Furthermore, as clinical trials continue to fail recruitment targets, researchers agree that a change with recruitment methods is needed. As noted by Tanner, Kim, Friedman, Foster, and Bergeron (2015), current strategies for recruitment in clinical trials involve primary investigators recruiting patients personally, by utilizing patient databases, and through printed materials. These strategies continue to be used because primary investigators are familiar and comfortable with them (Tanner et al., 2015). However, these strategies do not include all individuals such as those who live in underserved areas, highlighting the need for a strategic shift that will help address these issues.

Key Terms in this Chapter

Minorities: Individuals who are either culturally, ethnically, or racially different from a dominant group of individuals.

Clinical Trials: A type of clinical research where individuals are assigned to intervention(s) to evaluate the outcomes.

Clinical Research: Research that directly involves humans or that utilizes materials from humans (such as blood or tissue).

Protocol: A document which describes the purpose, design, and methodology for a clinical research study/clinical trial.

Principal Investigator: A primary researcher who is responsible for conducting a clinical trial as per protocol or investigational plan.

Participant Recruitment: Finding and enrolling the best-qualified patients in a clinical trial in order to answer research question.

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