Cooperative Agreement U01FD007782

ADVANCING EQUITY THROUGH THE ALLIANCE FOR REPRESENTATIVE TRIALS (ARC) PROGRAM TO DIVERSIFY AND BRING INDUSTRY-SPONSORED TRIALS TO COMMUNITIES OF COLOR AND UNDERREPRESENTED COMMUNITIES - PROJECT SUMMARY / ABSTRACT BACKGROUND. REPRESENTATION OF RACIAL AND ETHNIC MINORITIES IN CLINICAL TRIALS IS NEEDED TO ENSURE THAT REGULATED MEDICAL PRODUCTS REFLECT AND TREAT THE INTENDED TREATMENT POPULATION AND PRODUCE GENERALIZABLE RESULTS; HOWEVER, LIMITED KNOWLEDGE EXISTS ON THE EFFECTIVENESS OF ACTIONABLE SOLUTIONS TO IMPROVE DIVERSITY IN CLINICAL TRIALS AS WELL AS COST-EFFICIENT WAYS TO INCREASE COMMUNITY PRACTITIONER AND CLINICIAN CAPACITY TO PARTICIPATE IN CLINICAL RESEARCH. GOAL. THE PRIMARY PROJECT GOAL IS TO DEMONSTRATE THAT MINORITY-SERVING COMMUNITY CLINICIANS CAN BE TRAINED AND CERTIFIED TO BE PRINCIPAL INVESTIGATORS (PIS) FOR RANDOMIZED CLINICAL TRIALS AND REAL WORLD STUDIES AS WELL AS UPGRADE THEIR PRACTICES AS TRIAL SITES. METHODS. TO ACHIEVE THE THE GOAL, THE ALLIANCE FOR REPRESENTATIVE CLINICAL TRIALS (ARC), A MULTI-SPONSOR PUBLIC/PRIVATE PROGRAM ORGANIZED TO DIVERSIFY AND BRING CLINICAL TRIALS TO COMMUNITIES OF COLOR AND OTHER COMMUNITIES THAT HAVE BEEN UNDERREPRESENTED IN CLINICAL TRIALS, WILL BE SCALED UP BY INCREASING THE NUMBER OF MINORITY-SERVING CLINICIANS WHO HAVE BEEN TRAINED TO BE PRINCIPAL INVESTIGATORS (PI) TO LEAD DRUG AND DEVICE RANDOMIZED CLINICAL TRIALS. WE PROPOSE TO DEVELOP THE KNOWLEDGE, PRODUCTS, AND PROCESSES NEEDED TO EXPAND THE ARC INITIATIVE. OUR RESEARCH QUESTION IS: WILL ARC BE SUCCESSFULLY ADOPTED, IMPLEMENTED, AND SUSTAINED THROUGH EXISTING CHANNELS USING THIS IMPLEMENTATION PROCESS? A CASE STUDY WILL BE IMPLEMENTED TO EVALUATE THE EFFECTIVENESS OF THE ARC INITIATIVE ON IMPROVING MINORITY-SERVING PRACTITIONERS' AND CLINICIANS' CAPACITY TO PARTICIPATE IN CLINICAL RESEARCH IN A 12-MONTH PERIOD. OBJECTIVES. THE PROPOSED PROJECT WILL TRAIN AND CERTIFY COMMUNITY CLINICIANS TO BE PIS, PLACE STUDY COORDINATORS IN THEIR PRACTICE, AND UPGRADE THEIR LOGISTICAL SYSTEMS SO THEY CAN SUPPORT CLINICAL TRIALS. ONCE CERTIFIED AS PIS, THESE PRACTICES WILL BE ENROLLED IN THE CLINICAL INVESTIGATIVE SITE NETWORK (CISN) AS A CLINICAL TRIAL SITE. CERTIFIED PRACTICES WILL IMMEDIATELY BE OFFERED THE OPPORTUNITY TO BE AN INVESTIGATIVE SITE FOR SEVERAL PRIVATELY FUNDED STUDIES THAT CISN IS MANAGING, AND CISN WILL CONTINUOUSLY REACH OUT TO PUBLIC/PRIVATE TRIAL SPONSORS TO BRING OTHER STUDY OPPORTUNITIES TO THEM. DISSEMINATION AND INNOVATION. A PROJECT EVALUATION WILL BE CONDUCTED TO ENSURE THAT THE TOOLS AND INTERVENTIONS USED ARE EFFECTIVE, RESPONSIVE, AND EQUIPPED FOR WIDESPREAD DISSEMINATION WHEN THE FUNDING ENDS. TO PREPARE FOR DISSEMINATION, WE WILL CONSULT WITH THE ASSOCIATION OF BLACK CARDIOLOGISTS TO REFINE ARC PROCESSES AND PRACTICES AND UTILIZE AN EVALUATION BOARD TO EVALUATE AND GUIDE PROJECT ACTIVITIES. PROJECT RESULTS ARE LIKELY TO IMPACT THE FIELD BY IMPROVING TECHNICAL ABILITIES AND CLINICAL PRACTICE TO: RECRUIT AND TRAIN MINORITY-SERVING COMMUNITY CLINICIANS TO IMPLEMENT CLINICAL TRIALS; CREATE A SUSTAINABLE SOLUTION TO IMPROVING THE RECRUITMENT AND RETENTION OF DIVERSE POPULATIONS IN CLINICAL TRIALS; AND CREATE AN INFRASTRUCTURE FOR COMMUNITY CLINICS TO PARTICIPATE IN CLINICAL TRIALS, INCREASING THE ACCESSIBILITY OF TRIALS TO UNDERREPRESENTED GROUPS. THE PROPOSED PROJECT IS INNOVATIVE BECAUSE IT SYSTEMATICALLY EXAMINES THE PROCESS OF EXPANDING THE ARC INITIATIVE, A POTENTIALLY SUSTAINABLE SOLUTION TO IMPROVING DIVERSITY IN CLINICAL TRIALS.