Clinical trial participation among economically disadvantaged populations

Background In April of 2000, the Food and Drug Administration's (FDA) Office of Special Health Issues (OSHI) examined the low participation rate of ethnic minorities in research studies and clinical trials. Research revealed that ethnic populations were less likely to participate in clinical trials partly because they lack information about clinical trials and the research process. Additionally, a literature review and environmental scan noted the lack of research data available on the interest and willingness of healthcare professionals from federally qualified health centers (FQHCs) to refer patients from economically disadvantaged populations to clinical trials. Introduction OSHI engaged healthcare professionals serving economically disadvantaged patients to learn why they do not refer more of their patients to clinical trials. Informal one-on-one interviews with healthcare professionals were performed to determine FQHCs gaps in knowledge about clinical trials and the medical product approval process, whether and how they access information, enroll and refer their patients to clinical trials and to gauge their trust in FDA, and the clinical research community. Methodology OSHI contacted several Federal agencies, the Indian Health Service, Health Resources Services Administration, Department of Veterans Affairs, and 10 Regional Health Administrators of the Department of Health and Human Services, to obtain help in identifying healthcare professionals who serve disadvantaged patients and were willing to participate in a telephone interview. Of the 20 names garnished, 15 healthcare professionals were interviewed. Summary From the 15 interviews, there were several key findings on the challenges in community settings that hinder healthcare professionals' willingness to refer patients to clinical trials: most community healthcare professionals (CHPs) see value in clinical trials in the medical product development process and that enrolling a diverse participant population is important to public health safety; generally CHPs trust the FDA, but many are confused about its role in clinical trials; since a patient visit is largely focused on acute illness and chronic disease, it leaves little time to explore clinical trials; some CHPs feel that informing their patients about clinical trials is part of their role; many CHPs are not aware of resources to locate information on clinical trials currently under way; most CHPs have referred a patient to a clinical trial, but the referrals are rare; referrals to clinical trials are largely based on understanding the trial, including its risks and benefits; most CHPs would like to have clinical trial information presented to them in-person.