While African Americans and Hispanics—especially women in these ethnic groups—are disproportionately affected by lupus, they are under-represented in clinical trials in lupus and other chronic diseases.1,2 With the help of a new federal grant, the ACR took the first step to address this lack of diversity in lupus trials this year.
The ACR’s Collaboration Initiatives (COIN) department and collaborators have launched Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a new program to develop and evaluate communication strategies for clinical trial personnel. MIMICT includes free educational materials to help clinical trial investigators build relationships with each other and with referring physicians in their areas, and, ultimately, to help them effectively communicate with African American or other minority patients with lupus. MIMICT is part of the ACR’s Lupus Initiative.
Awareness Gaps
Barriers to minority participation in lupus clinical trials may exist in part because treating physicians lack awareness about current trials and their protocols, says Sheryl McCalla, senior director, collaborative initiatives, at the ACR. Historical events may also affect some patients’ trust of the medical profession, she adds.
“The lack of diversity in clinical trials reduces opportunities for discovering potential differences in the effects treatments may have in disparate groups of patients. Diverse sampling in trials can tell us how a treatment may affect people in different patient populations,” Ms. McCalla says. “So there is a great benefit to society—to see how treatments work in different patients—and also to improve the treatment of patients in general. But there are many challenges in getting people to enroll in clinical trials.”
Clinical trial results often do not reflect the actual patient population with this disease, so diversifying participation can help refine the quality of study results, says Ms. McCalla.
The ACR will expand MIMICT with the help of a new, two-year grant from the U.S. Department of Health and Human Services Office of Minority Health. This project will be led by ACR members, Saira Z. Sheikh, MD, assistant professor, rheumatology, allergy & immunology, University of North Carolina at Chapel Hill, and Allen Anandarajah, MD, MS, associate professor, allergy, immunology and rheumatology, University of Rochester Medical Center, Rochester, N.Y. If it succeeds, the model may be adapted to boost minority trial recruitment in other diseases, says Ms. McCalla. Funding for the first year is $500,000, and the second year of funding is expected to be the same, she says.
MIMICT currently focuses on primary-care providers serving African American patients, but proposed future programs include materials for providers serving Latino patients, and nephrology and dermatology healthcare teams. In June and July, ACR staff evaluated how well MIMICT increased communication between referring providers and clinical trial sites in Georgia and North Carolina. Current materials include tips for clinical trial investigators to more effectively communicate with healthcare providers in their area and online guidebooks on ways to improve communication with African American patients about the value of clinical trials, including the pros and cons of participation. Download MIMICT educational materials at www.thelupusinitiative.org/mimict.
Physicians Rarely Mention Trials
Atlanta attorney Christopher Reed is an African American lupus patient serving as an advisor for the MIMICT program. Mr. Reed also serves as co-chair of advocacy for the Lupus Foundation of America’s Georgia Chapter and chair of the Advisory Council for the Georgia Council on Lupus Education Awareness. One reason African American and Hispanic lupus patients lack awareness about currently recruiting clinical trials is that their physicians never bring up the subject, says Mr. Reed.
“I’ve had a handful of rheumatologists and other medical providers as part of my team over the last 27 years since my diagnosis. In that time, probably only once has a doctor said to me, ‘Would you consider participating in a clinical trial?’” says Mr. Reed. “Patients don’t know what’s out there. Yes, there are organizations promoting clinical trials, but it’s rare that this information is communicated except by word of mouth.”
Even some landmark clinical trials for belimumab (Benlysta), the first biologic drug approved by the U.S. Food and Drug Administration (FDA) to treat SLE, such as BLISS-76, had low African American patient participation, says Mr. Reed.3 According to data presented by the Society for Women’s Health Research in 2011, African Americans comprise 12% of the U.S. population, but only 5% of participants in clinical trials.4
Mistrust of medical research is one potential barrier to greater minority participation, Mr. Reed says. “When you speak about clinical trials to African Americans, they think of Tuskegee,” referring to syphilis research conducted on African American men in the 1930s, in which patients were not given informed consent or proper treatment for their conditions. “They may say, ‘I don’t know if I want to participate in a clinical trial.’
“We need more open communication between patients and doctors about clinical trials, and doctors need to be more aware of patients’ sensitivities. MIMICT can help close those gaps and cultural differences,” says Mr. Reed.
Improved Communication
Patients may not know that clinical trial participation can include medications and regular checkups, says Ms. McCalla. MIMICT materials will help physicians start conversations and answer patients’ questions.
“We hope to create better understanding among front-line lupus care providers about clinical trials through MIMICT. For lupus, in particular, it is mission-critical to encourage a more diverse patient population in our clinical trials,” she says.
Clinical trials offer many benefits to African American and Hispanic patients who may struggle to afford care for their complex disease, says Mr. Reed.
“If you can’t afford medications or physician visits, a trial may be one way to access that,” he says. Without more diverse enrollment in clinical trials, “you are really missing a big component of the lupus patient population.”
To learn more about MIMICT and download free materials to help you start conversations with your African American patients about clinical trial opportunities, visit http://thelupusinitiative.org/mimict. Learn more: [email protected].
Susan Bernstein is a freelance medical journalist based in Atlanta.
References
- Somers EC, Marder W, Cagnoli P, et al. Population-based incidence and prevalence of systemic lupus erythematosus: The Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369–378.
- Califf RM. 2016: The year of diversity in clinical trials. U.S. Food and Drug Administration’s FDA Voice. 2016 Jan.
- Wallace DJ. Belimumab: Where are we three years after FDA approval? Curr Treat Options in Rheum. 2015;1:42.
- Dialogues on diversifying clinical trials. Society for Women’s Health Research and the U.S. Food and Drug Administration Office of Women’s Health. 2011 Sep.
