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.
