Increasing the Participation of Women and Minority Populations in Clinical Trials: Integrating Technology-Oriented Strategies into Clinical Research Practice

Introduction

As the healthcare industry shifts to a population health approach that focuses more on the prevention of diseases and chronic illnesses, technology continues to play a role in the delivery of care, the storing of patient records, and the tracking of health trends. 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, according to the U.S. Census Bureau (2015), females made up 50.8% of the U.S. population in 2014. However, according to the U.S. Food and Drug Administration (2015), women and minorities have historically been underrepresented in clinical trials. Consequently, one of the biggest challenges for the clinical research industry is the recruitment of women and minority populations. The term minorities will be used to describe many different races including individuals who are Hispanic or Latino, Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, and those who are of two or more races. Not only does the adequate inclusion of women and minorities in clinical trials lead to a better understanding about how to identify and treat disorders, but it also leads to more accurate diagnoses (Ma et al., 2014). Anwari et al. (2013) stated that the “comprehensive inclusion of diverse participants in clinical trials is essential in assuring generalizability of prevention, diagnostic, and treatment recommendations” (p. 1798).

According to the National Institutes of Health (2015), clinical studies are performed with humans who have consented to participate in order to help researchers gather information on how to prevent, identify, or treat diseases and conditions. The I-IV phases of clinical trials differ in their objectives, including the number of participants that are needed in order to adequately answer the research questions. For example, a Phase IV clinical trial is typically designed to further evaluate the long-term safety effects of a treatment or intervention that is already on the market and usually reaches the largest patient pool.