To ensure that clinical trial findings are generalizable to the public as a whole, participants should represent the patients who will be utilizing these products. However, ethnic minority groups in the USA are under-represented in most clinical trials, representing on average 5–15% of all trial participants. This is concerning as people in general often respond differently to medical products, and there is evidence that this is especially true when accounting for race and ethnicity. Implications related to this lack of representation include an evidence base that does not reflect populations for whom the cancer burden may be greatest, and enhanced potential for misdiagnosis that can widen health-care disparities. The most commonly cited factors that limit participation of ethnic minority patients in clinical trials include systemic or system-level factors, such as strict exclusion criteria, cost, transportation and convenience; and patient-level factors such as lack of awareness and/or knowledge of clinical trials that are available, misperceptions, mistrust of the health system, family pressures, religious beliefs and poor patient–provider communication.
The Increasing Minority Participation in Clinical Trials (IMPaCT) study used patient navigators (PNs) to address these system-level and patient-level factors, in order to enhance the recruitment and retention of African Americans (AAs) in therapeutic cancer clinical trials in the USA. The goals of the programme were to educate AA patients with cancer about clinical trial participation and to assist with recruitment and retention of AA patients with cancer in therapeutic clinical trials. PNs were specifically trained lay individuals who provided patients with educational resources, links to social and community services as well as practical support with transport and accommodation. Between 2007 and 2014, 424 AA patients with cancer were referred to IMPaCT. Of the 378 patients eligible for a clinical trial, 80.4% enrolled in a trial and 71.4% consented to receive PN support. Of those receiving PN support, 74.5% completed the trial, compared with 37.5% of those not receiving PN support. IMPaCT-enrolled participants were 4.88 times more likely to complete the clinical trial than AAs not receiving PN support. The two groups did not differ on key demographics of educational attainment, income, health insurance status and employment status. Participation of AAs in therapeutic cancer clinical trials increased from 9% to 16%.
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