Lupus Research Alliance and National Minority Quality Forum Launch Lupus Multi-Cultural Engagement Partnership
The Lupus Multi-Cultural Engagement Partnership (Lupus MCEP) was recently launched at an inaugural meeting in New York City to address the need to increase the number of participants in upcoming lupus clinical trials and to guarantee that ethnic and racial representation is considered.
The Lupus MCEP meeting was hosted by the Lupus Research Alliance and the National Minority Quality Forum and attended by 30 national specialists and key opinion leaders to discuss ways of enrolling the 35,000 participants needed to initiate the more than 120 clinical studies underway to test potential new treatments for lupus.
The number is required by the U.S. Food and Drug Administration (FDA) to provide enough data to demonstrate the safety and efficacy of these investigational treatments. However, based on current projections, enrollment might not make it to the required numbers, particularly among African-American, Hispanic/Latina, and Asian populations.
The challenge is worrying because these are thought to be populations that are at greatest risk for developing lupus, or for whom outcomes are predicted to be more damaging.
According to a press release, the difficulty in finding lupus trial participants is not a new phenomenon. It has been noted as one of the main reasons that only one treatment has been successfully tested and approved by the FDA in 50 years. It also has sparked questions about proportional racial representation, as studies have shown disparities in diagnoses and outcomes between different demographic groups.
Lupus MCEP meeting attendees identified key obstacles to recruiting patients for trials, including physicians’ reluctance to present clinical research as a treatment option, logistical limitations, lack of perceived benefit, and fear that symptoms might worsen.
Coming out of the meeting, a full report is expected to inform the development of new strategies that can help increase enrollment of traditionally under-represented populations in lupus clinical trials.
The National Minority Quality Forum was established in 1998 to address the critical need for strengthening national and local efforts to use evidence-based and data-driven initiatives to guide programs seeking to eliminate the disproportionate burden of premature death and preventable illness for racial and ethnic minorities and other minority populations.
The non-profit, non-partisan organization is dedicated to ensuring that high-risk racial and ethnic populations and communities receive optimal healthcare in the United States by partnering with healthcare providers, professionals, administrators, researchers, policymakers, and other stakeholders.
Besides these two organizations, the inaugural meeting welcomed representatives from other key organizations, including the American College of Rheumatology, Association of Black Cardiologists, Black Women’s Health Imperative, Lupus Clinical Investigators Network (LuCIN), Lupus Research Alliance’s Multi-Cultural Outreach Task Force, and the Kelly Fund for Lupus, among others.