The American College of Rheumatology (ACR) is launching two initiatives aimed at reducing racial disparities in lupus clinical trials. These programs include Training to Increase Minority Enrollment in Lupus Clinical Trials with CommunitY Engagement (TIMELY) and new Continuing Medical Education (CME) content targeted towards dermatologists and nephrologists.
Addressing Under-Representation in Lupus Clinical Trials
Systemic lupus erythematosus, commonly known as lupus, disproportionately affects African American and Hispanic populations, who often experience more severe symptoms, greater organ damage, and higher mortality rates. Despite this, these groups are significantly under-represented in lupus clinical trials. Starla H. Blanks, Senior Director of Collaborative Initiatives for the ACR, emphasized the organization's commitment to changing this disparity.
TIMELY Program Details
TIMELY is a two-year, $500,000 grant funded by the U.S. Department of Health and Human Services Office of Minority Health (OMH). It combines the ACR’s Materials to Increase Minority Involvement in Clinical Trials (MIMICT) model and its Community Health Worker Lupus Clinical Trials Training (LuCTT) model. This collaborative approach involves rheumatologists, nephrologists, dermatologists, and community health workers serving African American and Hispanic patients. The intervention aims to address both provider- and patient-reported barriers to lupus clinical trial participation.
Provider and Community Health Worker Training
Lupus patients often receive care from multiple specialty teams, which may face obstacles in making clinical trial referrals. TIMELY will provide education to trained providers and community health workers on addressing these barriers. This will increase awareness of how health professionals can collectively impact clinical trial literacy, diversity, and enrollment, according to Blanks.
The program will be launched in Raleigh-Durham, NC, and Rochester, NY, under the leadership of Dr. Saira Sheikh at the University of North Carolina at Chapel Hill and Dr. Allen Anandarajah at the University of Rochester Medical Center. Both Dr. Sheikh and Dr. Anandarajah have a successful track record, having previously led the ACR’s MIMICT project funded by OMH. The ACR hopes to develop an effective model that can be expanded to centers throughout the country.
Patient-Centered Approach
Dr. Saira Sheikh stated, "We define success as a dynamic state influenced by how well we design and deliver information that matches patients’ abilities, needs, and preferences." Dr. Anandarajah added, "We anticipate that a successful program will help develop a patient-centered approach in lupus clinical trials and bring it to line with aspirations for everyday patient care."
CME Content for Dermatologists and Nephrologists
In addition to TIMELY, the ACR is developing new CME content tailored to dermatologists and nephrologists, who play crucial roles in the care of lupus patients. Blanks noted that these providers may encounter patients exhibiting rheumatic disease symptoms and that the education will equip them with the necessary information for diagnosis and treatment. The ACR plans to launch the new CME content in spring 2022.
