New York, NY, January 27 — The Lupus Research Alliance (LRA) and its clinical affiliate Lupus Therapeutics (LT) announced two major initiatives to address underrepresentation of minorities in clinical trials and in the scientific research profession: Project CHANGE by LT and the Diversity in Lupus Research Program. The organization has tackled these disparities for decades and now embarks on this highly aggressive multi-pronged plan to achieve equity among people with lupus and professionals in this field.
Project CHANGE by LT to Increase Lupus Clinical Trial Participation among African Americans Led by Director of Health Equity at LRA and LT Ebony Scott, MSEd, MHC, the Lupus Therapeutics Project CHANGE by LT: Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities focuses on a community-based participatory research approach, health inequities and disparities in clinical trials. Under her direction, this program will develop multifaceted, comprehensive action plans that increase meaningful, equitable, and supported clinical trial awareness, participation, and retention (engagement) among African Americans diagnosed with lupus in the U.S. A collaborative team in three pilot locations will work with patients; hospitals; healthcare providers; women’s health groups; medical and nursing associations; medical, community-based, faith-based, and grass root organizations; as well as community leaders to tailor a specific Action Plan that fits each of their community’s specific and unique needs.
“Because lupus affects each person differently, it is especially important for the full range of patients living with lupus to participate in research so that we can work towards new treatments and ultimately a cure,” noted Ms. Scott. “However, too often treatments are not tested among the people who will need them most. Project CHANGE by LT will increase representation by people of color in lupus clinical research, particularly African Americans, so potential new treatments can be developed that work for each individual.” Watch this video to hear more about the program from Ms. Scott.
Lupus is an autoimmune disease that disproportionately affects people of color in both prevalence and severity of disease. In fact, lupus is the 5th and 6th leading cause of death among African American and Hispanic females 15-24 and 25-54 respectively – just behind cancer, heart disease and HIV.i Regarding lupus-specific clinical trials, a recent study found that only 14% of clinical trial participants included African Americans with lupus.[ii]
LRA Launches Diversity in Lupus Research Program Another disparity the LRA aims to alleviate is the lagging representation of minorities in the scientific research field. In a 2018 report the National Science Foundation details that African Americans, Pacific Islanders, Native Americans, and Hispanic individuals make up just over 10% of the scientific workforce despite accounting for more than 25% of the general population.[iii]
To foster the development of talented underrepresented minority early-career scientists, postdoctoral fellows, and research trainees interested in lupus research, the LRA is launching a comprehensive Diversity in Lupus Research Program. The three key areas include:
LRA Chief Scientific Officer Dr. Teodora Staeva noted, “In addition to financial support, the Diversity in Lupus Research Program will provide access to quality mentorship by leading lupus investigators, access to opportunities and resources for scientific and professional development as well as a supportive network of peer scientists, creating a close professional community.”
Building on Partnerships with Well-Respected Groups These new programs build upon the recommendations of the Lupus Multi-Cultural Engagement Partnership formed by the LRA and the National Minority Quality Forum to address the causes and potential solutions for the lack of inclusion in clinical trials of populations at greatest risk for lupus. A Meeting report, Addressing the Challenges of Clinical Research Participation Among Populations Disproportionately Impacted by Lupus presents many short- and long-terms strategies, some of which LRA has already undertaken and others in progress. The program is part of a multifaceted approach that included the pivotal Lupus Patient-Focused Drug Development (PFDD) Meeting hosted by the LRA, Lupus and Allied Diseases Association and the Lupus Foundation of America which produced a comprehensive report bringing 2,000+ diverse patient perspectives to the U.S. Food and Drug Administration drug review process on what people with lupus need from treatments. The LRA and LT continue to advocate with the FDA on behalf of the lupus community, providing feedback on patient concerns in addition to researching better ways to measure and evaluate the effectiveness and safety of potential new drugs.
Ensuring that the diversity of people with lupus is well represented in clinical research was the objective of a recently completed pilot study, Patient Advocates for Lupus Studies (PALS), a peer support program in which individuals living with lupus were trained to provide others with early education about clinical trials. The goal of the program was to improve clinical trial awareness, knowledge, and enrollment among people living with lupus, and study results will be available this year. LRA and LT also has worked with a wide range of groups such as Black Nurses Rock, Balm in Gilead, National Kidney Foundation, as well as clinical trial patient recruitment groups Antidote and Center for Information and Study on Clinical Research Participation (CISCRP) to make sure the full range of groups are knowledgeable about lupus and equipped to self-advocate for clinical trial opportunities.
“We were among the first to identify significant racial disparities in lupus care among underrepresented minority populations and have worked with the U.S. Office of Minority Health, U.S. Office of Women’s Health and the Surgeon’s General to conceptualize The Lupus Initiative run by the American College of Rheumatology and educate healthcare providers to improve diagnosis, prompt treatment and encourage racially diverse participation in clinical studies,” commented LRA President and CEO Kenneth M. Farber. “Ensuring that minorities are well-represented in clinical trials is a major priority for us. Building on this strong foundation, our work continues with renewed focus to achieve greater diversity among professionals researching lupus and engaging patients in clinical trials.”
About the Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors fund all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
About Lupus TherapeuticsLupus Therapeutics, an affiliate of the Lupus Research Alliance, aims to accelerate drug discovery and diagnostic innovation for all patients living with lupus. Lupus Therapeutics engages with biotechnology and pharmaceutical industry, as well as other investigators, to bring clinical trials to real people living with lupus. The organization aims to place the patient voice and community stakeholders at the center of strategic planning with the most creative clinicians and scientists in the world.
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[i] Yen, E. Y. and Singh, R. R. (2018), Brief Report: Lupus—An Unrecognized Leading Cause of Death in Young Females: A Population‐Based Study Using Nationwide Death Certificates, 2000–2015. Arthritis Rheumatol, 70: 1251-1255. doi:10.1002/art.40512.
ii Falussuni, et al. 2018. The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus.
[ii] National Science Foundation, National Center for Science and Engineering Statistics, SESTAT (1993–2013), and the National Survey of College Graduates (NSCG) (2015), See: https://www.nsf.gov/statistics/2018/nsb20181/report/sections/science-and-engineering-labor-force/women-andminorities-in-the-s-e-workforce
