Title: Utilizing a Lupus Clinical Trials Network to Advance Diversity and Representation in Clinical Trials: Perspectives, Preferences, and Unmet Needs of Patients, Providers, and Stakeholder Agencies Project Abstract Despite greater prevalence of systemic lupus erythematosus (SLE) among racial and ethnic minorities, marked gaps exist between patients affected by the disease and those represented in lupus clinical trials. Advancing enrollment of underrepresented populations is critical to ensure safety, efficacy, and equity in the process and products from clinical trials leading to the development of novel lupus therapeutics. However, few studies have explored the unique perspectives of patients and other key stakeholder groups to identify facilitators and tangible solutions to increase representation of diverse racial and ethnic participants, particularly in the context of lupus clinical trials. The goal of this proposal is to advance equity in lupus clinical trials by: a) leveraging novel data sources to advance evidence for enrollment of underrepresented populations in clinical trials, b) increasing understanding of diverse voices of key stakeholders in order to identify barriers, facilitators, and tangible solutions, and c) developing patient-centered clinical trial communication strategies and skills training for clinicians to improve participant diversity in lupus clinical trials. We will utilize a knowledge translation framework and mixed-methods approach in order to identify, exchange, synthesize, and disseminate insights to advance diversity in lupus clinical trials. We will leverage partnerships with the largest lupus clinical trials network in North America, the Lupus Clinical Investigators Network (LuCIN), and collaboration with key stakeholder groups to accomplish the proposed aims. The first specific aim of this project is to leverage existing data to establish a multivariable dataset of participant- and site-level characteristics within the lupus clinical trials network. The second specific aim is to describe the perspectives, preferences, and unmet needs of diverse stakeholder groups to improve participation of underrepresented groups in Phase II and III lupus clinical trials. Discussions will explore stakeholders’ perspectives on the barriers, facilitators, and tangible solutions at the individual, interpersonal, organizational, and systems-level to improve representation in lupus clinical trials; and assess stakeholders’ preferences for a practical patient-centered communication toolkit for clinicians to integrate clinical trial discussions into clinical care. The third aim is to synthesize practical approaches and resources to improve diversity and representation in lupus clinical trials. Using findings from Aim 2, we will present a white paper summary outlining a framework of practical solutions to improve representation in lupus clinical trials. As a tangible next step, we will develop a mockup of an online toolkit for clini...