Diversity in Lupus Clinical Trials: Why Is It Important?
Saira Sheikh, MD
University of North Carolina at Chapel Hill
Sheikh S. Diversity in lupus clinical trials: why is it important? [published online May 15, 2019]. Rheumatology Consultant.
There are substantial disparities in clinical trial participation across all disease states. Despite the fact there are approximately 120,000 clinical trials operating in the United States at any given time,1 minority participation in these trials falls short of a representative proportion of the population. African Americans represent approximately 12% of the US population but only 5% of clinical trial research participants.2 Similarly, Latinos make up 16% of the US population but only 1% of clinical trial research participants.2 This has critical implications for understanding drug mechanisms and, ultimately, for health outcomes. Diverse study populations in clinical trials can improve the generalization of findings on the efficacy and risk of medications. Ultimately, this helps us make better treatment decisions with and for our patients and improves health outcomes for everyone.
Low minority participation in clinical trials, including in lupus clinical trials, results in a lack of data on the effectiveness, safety, and adverse effects of treatment within populations who have the highest incidence, prevalence, morbidity, and mortality from certain diseases. For example, women are at higher risk of lupus than men, and the prevalence of lupus is higher among African Americans and Latinos compared with non-Hispanic whites. Hence, minority participation in clinical trials is essential to reduce lupus health disparities at both the individual and the systems levels. Also, indirect and direct costs of health disparities result in economic losses. Some published estimates place the burden in the hundreds of billions of dollars per year, with some direct medical costs from minorities being excess costs because of the health disparities.
It is important to be aware of these health disparities because they are substantial. Furthermore, there is evidence that patients in clinical trials have better outcomes than patients not enrolled in trials—even those in the control groups.4
When considering the reasons for why minorities are underrepresented in clinical trials, one can think about it in terms of patient-side and provider-side barriers. Important considerations when determining what is preventing patients from enrolling in clinical trials include access, opportunity, health literacy, and cultural impact, all of which may affect decision-making about clinical trials. Patients can feel uncertain about clinical trials, so providers need to build trust and confidence around the idea. Other patient-related barriers can include a lack of access to rheumatologists and sub-specialists; a lack of bilingual research staff or bilingual informational materials about clinical trials for Spanish-speaking Latino patients; and lower socioeconomic status, which can magnify the risk of facing barriers to clinical trials and care, because poverty introduces environmental barriers to health care, including lack of access to coordinated health care.
In terms of provider-side barriers, there is often a lack of knowledge and access to clinical trial information, particularly for primary care providers and rheumatologists who are practicing in the community. There are often inaccurate beliefs that minority patients will not understand or adhere to specific treatment protocols, which is an implicit bias. Logistical and practical concerns, such as lack of time to talk to patients during clinical visits and how to coordinate next steps, also hinder the ability to provide a patient with the right information about participating in a clinical trial.
Awareness is also an important factor. We recognize that there is a lack of awareness about clinical trials and poor understanding of how clinical trials are performed. Most patients who participate in a clinical trial learn about it from their provider.5 What I think is most striking—and the area that has the most potential for impact—is that more than three-quarters of patients state that they would have been willing to participate in a clinical trial if they had had the opportunity. We as specialists need to do better at providing the right information to our patients for the right opportunities.
In conclusion, diverse study populations for clinical trials can improve generalization of findings on the efficacy, adverse effects, and risk of medications, helping patients make better treatment decisions with their provider and improving health outcomes overall. Increasing minority enrollment in clinical trials can be a key component of health disparity reduction efforts.
Our goal is to work to ensure that all patients with lupus across the country are informed and educated about participation in clinical trials, which may provide opportunities to access new and cutting-edge therapies, and to enable rheumatologists to build effective partnerships with colleagues in primary care and subspecialties to achieve this goal.
- Map of all studies on ClinicalTrials.gov. https://clinicaltrials.gov/ct2/search/map. Accessed May 9, 2019.
- Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials. Washington, DC: Society for Women’s Health Research; Food and Drug Administration Office of Women’s Health. September 22-23, 2011. https://www.fda.gov/media/84982/download. Accessed May 14, 2019.
- The Henry J. Kaiser Family Foundation. Disparities in Health and Health Care: Five Key Questions and Answers. https://www.pcpcc.org/resource/disparities-health-and-health-care-five-key-questions-and-answers. November 2012. Accessed May 14, 2019.
- Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162(15):1682-1688.
- Comis RL, Miller JD, Colaizzi DD, Kimmel LG. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. J Oncol Pract. 2009;5(2):50-56.
Saira Sheikh, MD, is a rheumatologist and allergist-immunologist and director of the Lupus and Clinical Trials Programs at UNC Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill in North Carolina.