American College of Rheumatology receives grants to support development of lupus clinical trials

The American College of Rheumatology (ACR) today announced the receipt of two, two-year grants from the Office of Minority Health (OMH) to support the development of programs that aim to increase the recruitment and enrollment in lupus clinical trials of minority populations affected by lupus.

"This is the sixth year ACR has been awarded a grant from the OMH. We are very excited to work with our members and partners to expand programs that focus on improving minority participation in clinical trials," says Sheryl McCalla, JD, Senior Director of Collaborative Initiatives (COIN) at the ACR. "Clinical trial results often do not reflect the entire lupus patient population. The lack of diversity in clinical trials reduces opportunities for discovering potential differences in the effects a treatment may have in disparate groups of patients, but there are challenges in getting people to enroll in lupus clinical trials. Therefore, over the next two years, COIN will work with ACR member-experts on the Materials to Increase Minority Involvement in Clinical Trials (MIMICT) and the Community Health Worker Lupus Clinical Trials Training (LuCTT) projects to address some of these challenges."

ACR will utilize $500,000 in funds from a two-year OMH grant to develop, evaluate, and disseminate modifications of the ACR's current model for the MIMICT program model developed in 2017 with OMH grant funding to increase minority participation in lupus clinical trials. The initial MIMICT program helped clinical trials sites and providers to work together to deliver accurate, trusted, and understandable information to people with lupus so that they can make informed decisions about participation in clinical trials. Over the next two years, ACR will expand and modify MIMICT by broadening the pool of providers and patients to which it applies.

The ACR has partnered with two of its member- experts to apply their distinct experiences and resources for the benefit of MIMICT. Dr. Saira Z. Sheikh, MD, Assistant Professor, Rheumatology, Allergy & Immunology, University of North Carolina (UNC) at Chapel Hill, who is Director of the Lupus and Clinical Trials Programs at the UNC Thurston Arthritis Research Center and Allen Anandarajah, MD, MS, Associate Professor, Allergy, Immunology and Rheumatology, University of Rochester Medical Center. Dr. Sheikh will harness UNC's collective expertise in developing clinical trials education programs for minorities to the benefit of MIMICT.

"The modified MIMICT program will include projects that focus on primary care providers serving Latino patients, and health teams specializing in nephrology and dermatology (including physician assistants, nurse practitioners, nurses and others) as referral sources," says Dr. Sheikh. "Our goal through this important national initiative is to ensure that all lupus patients, across the country are informed and educated about participation in clinical trials, which may provide opportunities to access new and cutting edge therapies, and to enable rheumatologists to build effective partnerships with colleagues in primary care and sub-specialties to achieve this goal."

Dr. Anandarajah will utilize the strategies and lessons learned from his Improve Quality in Low-income, Underserved, Poor, Underprivileged, SLE patients (IQ-LUPUS) project to inform MIMICT in connection with building community partnerships, and evaluating minority clinical trial education and participation programs.

"Building genuine connections and trustworthy partnerships with the community are critical to accurately identifying the educational needs of the under-educated portion of the minority populations." Dr. Anandarajah explains.

At the same time, the ACR will utilize $375,000 in funds from a second two-year OMH grant to develop a separate program related to clinical trials that will focus on minority recruitment. Using a different approach from MIMICT, the LuCTT program will aim to promote the recruitment and enrollment of minority populations affected by lupus into clinical trials by making use of community health workers (CHW) as referral sources. The LuCTT program model will include multiple interconnected components that will be used by state, local, and community organizations to host regional CHW training summits on lupus clinical trial recruitment support.

The ACR has partnered with Albert Einstein College of Medicine in Bronx, NY and local CHW networks for implementation of specific aspects of the LuCTT program. Irene Blanco, MD, Associate Professor of Medicine - Rheumatology and Associate Dean of Diversity Enhancement at Albert Einstein College of Medicine will provide the vital support necessary to ensure cohesiveness in preparation and planning of content development, implementation, evaluation, dissemination and publication.

"We will be able to leverage the amazing work already accomplished by CHWs to now have an increased focus on lupus and lupus clinical trials," says Dr. Blanco.

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