“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.
