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

Introduction

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., 2014_b). However, despite this, they are the least represented U.S. ethnic group in clinical trials (Ma et al., 2014_b).

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, Clinicaltrials.gov noted having an outstanding 191,938 studies listed across 190 countries (Clinicaltrials.gov, 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.