Underrepresentation in Cardiovascular Disease Clinical Trials

Abstract

Background: When it comes to inequalities in medicine, there are countless avenues through which barriers are placed that lead to worse health outcomes for marginalized groups. One inequality that isn't mentioned nearly as often is how difficult it is for marginalized groups to participate in clinical trials. As such, the results from these studies are most broadly applicable only to white men, the most common demographic to participate, as opposed to people from all races and backgrounds. The project for this summer is the first step in a longitudinal project meant to identify and address the barriers that preclude marginalized groups from participating. Methods: There are three steps to researching this underrepresentation. The first is a literature review. In this step, we searched for any existing literature about the presence of underrepresentation in cardiovascular disease (CVD) clinical trials as well as in other fields. From this literature, the results were analyzed, to ensure the validity of conducting our study, as well as the methodology of the studies, to ensure our own research will follow the established methods of other successful studies. The second is to interview experts in the field, such as others who research this topic as well as cardiologists and community leaders, to determine what barriers and solutions they believe decrease participation of POC patients. The final step is to conduct our own clinical trial that addresses those barriers by applying solutions discerned from the previous steps and creates a successful methodology to properly include underrepresented patients in the future. For this summer, we made it to the second step. Results: The literature review found that there indeed exists a discrepancy in participation of POC patients in clinical trials. Specifically, while the percent of overall nonwhite participation has increased, the number of black participants has remained the same since January of 2001, indicating that while there has been improvement in this inequality, there is still a need to improve recruitment for black participants specifically (Tahhan et al., 2020). Findings from the literature review also indicated potential barriers for underrepresented groups, including mistrust of clinical trials as a whole, time/resources constraints, and just a general lack of awareness of the existence of clinical trials (Clark et al., 2019). While determining solutions is part of the future directions of this study, Clark, et al. seems to suggest that the best solutions will address the interface between patients, physicians, and clinical trial teams on all 3 levels. One final conclusion from the literature review is the fact that there was “no price to pay for achieving diversity” (Batchelor et al., 2021). In looking at studies all over the country from 2 US National Coronary Stent Registries, a higher focus on increasing racial minority groups and women did not negatively influence research site performance, and possibly could lead to lower protocol deviation rates. While the interview portion of the study has yet to be completed, we have interviewed Francine Epperson, a researcher who has investigated barriers to black patient participation in Alzheimer’s clinical trials. Her study concluded that one facilitator to increase black participation is a “return of results to make informed decisions about their health” (Eliacin et al., 2023). Too often, clinical trials take results from participants and apply them elsewhere, with their participants being none the wiser as to what they helped accomplish. By applying and sharing the results of the studies to the communities that are recruited, we establish trust and a continued partnership, something that is desperately needed to help address the underrepresentation in cardiovascular disease clinical trials. Future Directions: The next steps in this project include conducting expert interviews, including cardiologists but also public health and community leaders, to determine barriers to participation and potential solutions. The final step involves consolidating the first two steps into solutions that can be used to conduct a clinical trial that minimizes barriers and increases rates of nonwhite participation. Citations: Batchelor, W. B., Damluji, A. A., Yong, C., Fiuzat, M., Barnett, S. D., Kandzari, D. E., Sherwood, M. W., Epps, K. C., Tehrani, B. N., Allocco, D. J., Meredith, I. T., Lindenfeld, J., O'Connor, C. M., & Mehran, R. (2021). Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J, 236, 37-48. https://doi.org/10.1016/j.ahj.2021.02.003 Clark, L. T., Watkins, L., Pina, I. L., Elmer, M., Akinboboye, O., Gorham, M., Jamerson, B., McCullough, C., Pierre, C., Polis, A. B., Puckrein, G., & Regnante, J. M. (2019). Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol, 44(5), 148-172. https://doi.org/10.1016/j.cpcardiol.2018.11.002 Eliacin, J., Polsinelli, A. J., Epperson, F., Gao, S., Van Heiden, S., Westmoreland, G., Richards, R., Richards, M., Campbell, C., Hendrie, H., Risacher, S. L., Saykin, A. J., & Wang, S. (2023). Barriers and facilitators to participating in Alzheimer's disease biomarker research in black and white older adults. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 9(2). https://doi.org/10.1002/trc2.12399 Tahhan, A. S., Vaduganathan, M., Greene, S. J., Alrohaibani, A., Raad, M., Gafeer, M., Mehran, R., Fonarow, G. C., Douglas, P. S., Bhatt, D. L., & Butler, J. (2020). Enrollment of Older Patients, Women, and Racial/Ethnic Minority Groups in Contemporary Acute Coronary Syndrome Clinical Trials. JAMA Cardiology, 5(6), 714. https://doi.org/10.1001/jamacardio.2020.0359