Building hybrid operations to promote equity (hope) and improve clinical trial access across north carolina

This Cooperative Agreement award from the Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103) provides $500,000 in funding to the University of North Carolina at Chapel Hill (UNC-CH) to establish the "Hybrid Operations to Promote Equity (HOPE)" initiative. The goal of this project is to address health disparities in North Carolina's diverse patient population by engaging local healthcare providers, implementing digital health tools, and developing specialized infrastructure to facilitate patient referrals and education on clinical trial opportunities, particularly in underserved communities. The award aims to create a HOPE network of healthcare providers across North Carolina with access to clinical trial opportunities, while also piloting hybrid decentralized clinical trial efforts to expand awareness and participation in cancer-related clinical trials. This funding will support UNC-CH's efforts to leverage the capabilities of both local healthcare providers and academic medical centers to improve clinical trial access and diversity across the state.

Abstract

The landscape of clinical research is in a constant state of evolution as a greater understanding of unmet patient needs and current clinical trial limitations are exposed, necessitating innovative solutions to address the challenges encountered by traditional clinical trial paradigms. One of the most pressing issues is the difficulty in recruiting and retaining diverse patient populations, leading to significant underrepresentation of minority groups, rural communities, elderly patients, and individuals with limited access to healthcare resources. This lack in diversity not only skews our understanding of treatment efficacy and safety but also compromises the generalizability of data generated from traditional trials. In response to these challenges, hybrid decentralized clinical trials (dcts) have emerged as a promising alternative. Hybrid dcts allow for tasks aligned with clinical practice to be performed by local health care providers (hcps) with their established patient relationships and limit clinical trial site visits to those with complex procedures that require extensive knowledge of the investigational product. By leveraging the capabilities of both local hcps and academic medical centers, implementing digital health tools, and minimizing the need for frequent in-person visits, hybrid dcts prioritize patient comfort and convenience while breaking down geographic and socioeconomic barriers. Here we outline a comprehensive plan to establish the hybrid operations to promote equity (hope) at the university of north carolina- chapel hill lineberger comprehensive cancer center (lccc). This proposal will address the health disparities within north carolina's diverse patient population where nearly 30% of individuals identify as belonging to a minority race across vast rural and urban regions. By engaging local healthcare providers in BI- directional educational efforts and creating use-friendly tools, we aim to facilitate patient referrals and education on clinical trial opportunities, particularly in underserved communities. Additionally, our approach includes the development of specialized infrastructure and oversight procedures to streamline internal hybrid DCT development and optimize clinical and regulatory procedures. Success of these endeavors will create a hope network of healthcare providers across the state of NC with access to clinical trial opportunities for their patients with most/all assessments occurring locally and will develop hope infrastructure to pilot hybrid DCT efforts to expand awareness of and participation in clinical trials addressing disparities in cancer prevention, treatment, and control across NC.