VIRTUAL—Although lupus is one of the most common causes of morbidity and death in patients of color, these individuals are not adequately represented in most clinical trials studying the disease.1,2 With this fact in mind, a session of the 2023 ACR Diversification of Clinical Trials Summit, which took place in July, focused on Engaging Diverse Participants in Lupus Clinical Trials.
The Patient Advocate Perspective
The first speaker was patient advocate Stacey Kennedy-Conner, family and community engagement specialist, lupus representative and member of Patient Advocates for Lupus (PAL) Studies at Lupus Therapeutics, Chicago Public Schools. Mrs. Kennedy-Conner discussed several barriers that prevent patients from engaging in clinical trials, such as fear of being a guinea pig, not understanding the underlying lupus diagnosis and not having a trusted partner in the medical sector. She also addressed the history of ethical abuses in clinical trials and research.
Mrs. Kennedy-Conner listed the reasons she chooses to participate in clinical trials, such as the desire:
- To advance treatments;
- To help better represent patients of color and other minority groups in the scientific literature; and
- To help find a cure for lupus.
One program that seeks to increase minority participation in clinical trials is the PAL program. This initiative pairs adults with lupus who are interested in learning about clinical trials with a PAL peer—someone who has lupus, has been in a clinical study and has been trained by the PAL program to provide education. Mrs. Kennedy-Conner noted that such initiatives are instrumental in addressing misconceptions and increasing awareness about the importance of lupus clinical trials.
Aleta McLean, LPC, senior director of client services and outcomes tracking, Open Hand, Atlanta, shared the story of her own lupus diagnosis, which was delayed and led to a great deal of pain and suffering while she waited for treatment. Thus, she encourages patients with lupus to participate in clinical trials to help develop methods that lead to quicker, more accurate diagnosis and fewer medication side effects.
Mrs. McLean also noted the fear of the unknown and the potential for misinformation about medical research may dissuade many from participating in clinical trials.
She and other speakers noted that clinicians should broach the topic of clinical trial participation as a general concept in an appointment early in the relationship, and work on building rapport over time. Additionally, clinicians and researchers should discuss if clinical trial participation will take time away from the patient’s work and family.
Fear of the unknown & the potential for misinformation about medical research may dissuade many patients from participating in clinical trials.
Patients as People
“Do you know what is important to the lives and experiences of patients with lupus? Do you know who the patient is as a person before they enroll in a clinical trial?” asked Monique Gore-Massy, national lupus advocate/global patient consultant.
Mrs. Gore-Massy explained specific ways to attract diverse patients to clinical trials, such as talking with them about proposed trial protocols, communicating with them even when they don’t meet criteria for a specific trial, using digital spaces to connect with them and involving patients in the development of patient education materials. She also suggested reaching out to community partners and primary care doctors who have long-term relationships with their patients.
Several speakers advised health professionals to look at each patient in a holistic manner, seek to understand the people who are important in their lives and view clinical trial involvement with patients as a means to advance science and to become a part of, and engage deeply with, the lupus community.
A Focus on Equity
Richardae Araojo, RDML, PharmD, MS, associate commissioner for Minority Health and director of the Office of Minority Health and Health Equity (OMHHE), U.S. Food & Drug Administration (FDA), Rockville, Md., provided the event’s keynote address. She described the work of her office in engaging with a diverse group of patients. Its general goal is to make health equity a reality for all patients across many medical specialties and areas of health.
Dr. Araojo discussed the myriad means by which the OMHHE provides patient-oriented educational materials, including fact sheets in multiple languages, brochures, infographics, web pages, listening sessions and podcasts. She also discussed the OMHHE Enhance Equity Initiative, which has three main aims:
- To support efforts to enhance diversity in clinical trials;
- To increase data available on diverse groups that include those of varying ethnicity, race, age, disability status and geographies; and
- To amplify the FDA’s communication with diverse consumers and stakeholders to understand patient preferences and unmet needs.
Additionally, the FDA supports the Health Equity Innovation Award. This grant supports research that strengthens and advances minority health and health equity research, specifically to increase knowledge on how to support diversity in clinical trials, datasets and collections of patient stories. Learn more online.
Increasing Awareness
Saira Z. Sheikh, MD, Linda Coley Sewell Distinguished Professor of Medicine, University of North Carolina, Chapel Hill, described the ACR Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program.
This program, based on a two-year, $500,000 grant, combines the ACR’s Materials to Increase Minority Involvement in Clinical Trials (MIMICT) model with its Community Health Worker Lupus Clinical Trials Training model. Its goal is to enhance collaboration among practicing rheumatologists, nephrologists, dermatologists and community health workers who serve Black and Latinx patients and break down barriers to participation in lupus clinical trials. The program aims to increase providers’ knowledge about these barriers to participation, positively influence attitudes about referring under-represented patients to trials, support providers’ belief that they can competently discuss clinical trial opportunities with patients and increase providers’ intentions to begin referring patients to clinical trials.
The key educational resources used in the TIMELY program include online modules tailored to the learning needs of rheumatologists, nephrologists and dermatologists, and modules for community health workers. These materials are designed to prepare participants to conduct outreach and education on clinical trials with Black and Latinx patients. The program is currently being employed and evaluated in North Carolina and western New York under the leadership of Dr. Sheikh and Allen P. Anandarajah, MD, MBBS, professor of medicine, Division of Allergy/Immunology and Rheumatology, University of Rochester, New York.
The U.S. South
Pamela Payne-Foster, MD, MPH, professor of community and population health, University of Alabama, Tuscaloosa, discussed the Deep South Health Equity Lupus Education Project (DS HELP), which seeks to increase the participation of patients with lupus, primary care providers and health disparity researchers and clinicians who are Black in clinical trials for lupus. The interventions for these groups include existing resources, such as the online Lupus Conversations program and the MIMICT program from the ACR. Other new resources include a conference using innovative approaches to disseminate information and a lupus research development program for both clinicians and biosocial researchers who work in predominantly Black communities.
Although the recruitment of participants for DS HELP was challenging, Dr. Payne-Foster noted that interesting lessons were learned through discussions in the program. Concerns about the distances between clinical trial sites and patients’ homes, fear of side effects from experimental medications and unease about the possibility of increased disease activity resulting from participating in trials were all raised.
Nurses
Finally, Joy Buie, PhD, MSCR, RN, director of research, Lupus Foundation of America, Charleston, S.C., discussed the Increasing Minority Participation and Awareness in Clinical Trials (IMPACT+) initiative. The goals of this program are threefold:
- To use an accredited curriculum to increase the knowledge of nurses about clinical trials and use the Popular Opinion Leader model to encourage the participation of Black patients in lupus trials;
- To educate people with lupus about clinical trials and the barriers to enrollment; and
- To determine the feasibility of using patient navigator-led clinical trial educational initiatives to increase Black participation in trials.
The training was built on the Rheumatology Nurses Society Lupus Conversations course and was delivered at a virtual summit in April 2022. The program taught nurses about lupus health disparities, outreach to geographically and demographically at-risk communities, and treatment options, including clinical trial participation. (View the online program for continuing nursing education credit until April 2024.)
Through this program, Dr. Buie and colleagues have found that adapting the Lupus Conversations model proved effective in increasing knowledge among nurses. They also found that nurse-led interventions and patient follow-up are key to understanding the overall effectiveness of such educational programs as IMPACT+.
Big Pharma
The session’s final panel discussion focused on the role of the pharmaceutical industry in supporting the diversification of clinical trials. The first speaker was Sergio Arce, MD, PhD, medical director, global clinical development, autoimmune diseases, RemeGen Biosciences, San Francisco.
Dr. Arce noted that racially and ethnically distinct subgroups of the U.S. population often respond differently to medical products. These differences are likely due to such factors as genetics, metabolism, drug elimination, diet, environmental exposure and socioeconomic variables—among other things. This underscores why minority participation in clinical trials is important—to properly understand treatment efficacy and safety in different patient populations.
With this in mind, Dr. Arce discussed a clinical trial of telitacicept and the plan to focus on minority recruitment in the trial.3 As part of the plan, researchers are using a patient-centric approach and outreach to the minority community, ensuring patient education materials are easily accessible and the website is patient-oriented, as well as including involvement of church and religious leaders in the community. From a global perspective, the focus is on enrolling subjects from varying geographic regions, such as Central and South America and Asia.
For this clinical trial, a stratified block randomization method will be used, with stratification factors that include region. Additionally, researchers will do a subgroup analysis for pharmacokinetics, pharmacodynamics, efficacy and safety end points across patients of different races, ethnicities, sex and ages.
Next, Coby Hobar, MD, clinical development lead, Bristol-Myers Squibb, Tampa, Fla., discussed several barriers to clinical trial participation for under-represented patients. From the standpoint of clinical trial sponsors, their understanding of the effect of trials on a patient’s daily life may vary. They may also have limited interest in involving inexperienced sites and investigators in a trial, even if it increases the diversity of participants. They may also lack direct communication with sites about the needs and importance of diversity in a clinical trial.
For research sites, expensive start-up costs, lack of diversity among investigators and clinical staff, bias in which patients are referred to clinical trials, and lack of community engagement may all play a role in contributing to the problem. Thus, Dr. Hobar noted the biopharmaceutical industry has promised to commit to working with patients, advocacy groups, regulatory authorities, healthcare providers, academics and policymakers to define systematic and impactful approaches to enhance the diversity of clinical trial participants and help reduce healthcare disparities.
Finally, Jodi Bridge, HonsBSc, senior clinical operations lead, Roche/Genentech, Toronto, spoke about how to operationalize the pharmaceutical industry’s role in engaging diverse participants in clinical trials. On the subject of embedding institutional commitment, Mrs. Bridge noted the industry can, and should, invest in infrastructure, protocol designs and study-specific diversity and inclusion plans to help bolster minority participation. She explained that it’s essential to understand and incorporate patient voices into research by identifying and mitigating patient barriers, meeting patients where they are, supporting research sites in their efforts to support patients and integrating patients at all stages of the study life cycle. Finally, the pharmaceutical industry must forge and support ongoing relationships with under-represented communities, clinicians, patients and advocacy groups with the goal of getting everyone on the same page to support diverse recruitment and retention in clinical trials.
In Sum
The summit was successful in educating the audience about the importance of engaging diverse participants in lupus clinical trials. Clearly, a great deal of work remains to be done, but the sessions represent an important first step in making a brighter future a reality for all.
Jason Liebowitz, MD, is an assistant professor of medicine in the Division of Rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York.
References
- Lim SS, Helmick CG, Bao G, et al. Racial Disparities in mortality associated with systemic lupus erythematosus – Fulton and DeKalb counties, Georgia, 2002–2016. MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):419–422.
- Falasinnu T, Chaichian Y, Bass MB, et al. The representation of gender and race/ethnic groups in randomized clinical trials of individuals with systemic lupus erythematosus. Curr Rheumatol Rep. 2018;20(4):20.
- News release: RemeGen announces preliminary results of phase iii confirmatory study of telitacicept for treatment of systemic lupus erythematosus (SLE) in China. RemeGen Co. Ltd. 2022 Sep 19.
