Minority Enrollment to Clinical Trials: Road to Increased Access

Abstract

For the outcome of clinical trials to have validity, participants should represent the patients that will be using the medical products, though this is often not the case. Racial and ethnic minorities are underrepresented in cancer clinical trials for a variety of reasons. This is a concern because people of different ages, races, and ethnicities may react differently to medical products. The estimated extent of racial disparities in clinical trial access varies in the literature, yet recent reports-such as the FDA's 2018 Drug Trials Snapshots-indicate the presence of a remarkable imbalance. A total of 5157 patients participated in oncology trials that led to approvals of 17 new drugs. Overall, 38% of all participants were women, 68% were White, 15% were Asian, 4% were Black or African American, 4% were Hispanic, and 50% were 65 years and older.1 These proportions sharply contrast with the racial distribution in the general United States population (76.6% White, 13.4% Black or African American, 5.8% Asian, 18.1% Hispanic or Latino). Further, only 36% of the trial participants were residents in the United States, which is a reflection of the increasingly international nature of phase 3 oncology trials designed to support the worldwide marketing plans of the study sponsor. According to US Census Bureau projections, more than half of the population in the United States is expected to be other than non-Hispanic White by 2045.2 In the absence of proactive planning, corrective measures, and systematic and effective intervention, the disparity between the clinical trial population and the changing population of patients with cancer in the United States is likely to worsen in the coming decades. What can be done to reverse this trend and enhance clinical trial enrollment by minorities? Increasing minority representation in the health care professions will enhance the ability of the patients to feel more comfortable with the recommended options, including clinical trial participation. In addition, the outreach of health care opportunities to neighborhoods closer to patients' homes will allow access to those without consistent transportation. Eligibility criteria that allow for patients with more co-morbidities to enroll when possible will also increase minority enrollment as well as represent a more real-world population on the study. Another recent improvement is the congressional approval of the Clinical Treatment Act, which requires Medicaid to cover the routine clinical care costs of patients associated with participation in clinical trials. Since Medicaid serves a large portion of individuals from racial and ethnic minority groups, this legislation will remove some barriers to participation in clinical trials for this patient population. With a more representative patient population, the results of these clinical trials will have more accurate outcomes in real-world patients with the illness in question. In addition, the racial and ethnic minority groups will benefit with this increased access to clinical trials and cutting-edge health care opportunities.

Keywords: clinical trials; health disparities.