The COllaborative INitiatives (COIN) department of the American College of Rheumatology (ACR) is currently working with ACR/ARHP members and external collaborators to develop educational materials for healthcare providers to increase participation of African Americans in lupus clinical trials. Once the materials are completed they will be evaluated and disseminated. The U.S. Department of Health and Human Services Office of Minority Health funds this yearlong project.
Minority participation in lupus clinical trials is essential to reduce lupus health disparities at the individual and system levels. At the individual level, close examination of clinical trial participation suggests an inequitable distribution of benefits and risks. Low-income and minority participants are overrepresented in Phase I studies involving healthy volunteers, and underrepresented in Phase II and Phase III research, which offers the most possible benefit for participants with the condition in question. At the system level, low minority participation in clinical trials on lupus can result in a lack of data on the effectiveness, safety, and side effects of treatment within populations with highest incidence, prevalence, morbidity, and mortality.
The barriers to minority participation in clinical trials are two sided, including patient-side barriers to participation and provider-side barriers to referring patients. The project, entitled Materials to Increase Minority Involvement in Clinical Trials (MIMICT), addresses aspects of both sides of the barriers. MIMICT will consist of educational and distribution toolkits with materials intended to increase providers’ knowledge, attitudes, self-efficacy, and intentions to refer African American patients to lupus clinical trials and decrease their barriers to learning about clinical trial opportunities. At the conclusion of the project there will be:
- A complete version of MIMICT tailored for providers who serve African American patients, including educational and distribution toolkits, culturally and linguistically appropriate patient materials, and provider and clinical trial site quick-start guides.
- MIMICT evaluation results.
- Clinical trial site partnerships.
- An action plan to distribute MIMICT nationwide.
Once the initial materials are completed, we will work with clinical trial sites in three areas with large African American populations to explore the use of the distribution and educational toolkits in real-world settings: Atlanta, GA; Research Triangle, NC; and Cleveland, OH.
The COIN department highlights rheumatology to an extensive network of partners by using lupus and other rheumatic diseases as case studies for treating complex disease, advancing health equity, eliminating health disparities, and improving patient quality of life. COIN achieves this through its continually growing network including public, private, and community organizations, and most importantly, its members.
To learn more about MIMICT, please visit us in the ACR Discovery Center, located in the Exhibit Hall.