Building a Framework for Equity Enrollment in Oncology Trials

Building a Framework for Equity Enrollment in Oncology Trials In the United States, adults with cancer have only a 3% participation rate in clinical trials. Introduction » In the United States, adults with cancer have only a 3% participation rate in clinical trials.1 Low participation rates are especially common among minorities and underserved populations in spite of their bearing a disproportionate burden of disease.2-4 For example, patients aged 65 or older represent nearly two thirds of cancer patients but account for less than one third of clinical trial enrollees.5 Minority or underserved populations include those of low income, the elderly, racial or ethnic minorities, women, or residents of rural areas. The gap in representative enrollment limits the knowledge base for determining the effectiveness and safety of strategies for treating cancer. When an individual study has a homogeneous patient population, investigators may not be able to detect differences in response to treatment between races or other groups. And it may be unclear whether study results are applicable to a broader, more heterogeneous population. Barriers to trial participation are unique to each patient, although common barriers include lack of health insurance, logistical challenges for completing study protocols, negative perceptions about clinical research, and lack of awareness about clinical research or specific trial opportunities. In oncology, minorities and underserved patients face particular challenges to enrollment. Recognizing the disparities, the National Institutes of Health requires that all research it sponsors, including cancer-related trials, include women and members of minority groups, unless their inclusion is inappropriate.6 Figure 1. Barriers to Participation & Enrollment COST OR LACK OF INSURANCE LOW LITERACY OR LANGUAGE DIFFERENCES NEGATIVE PERCEPTIONS ABOUT CLINICAL RESEARCH COMPLEX AND BURDENSOME PROTOCOLS LOGISTICAL CHALLENGES PHYSICIAN LACK OF AWARENESS clinipace.com 1

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