# Building Hybrid Operations to Promote Equity (HOPE) and improve clinical trial access across North Carolina

> **NIH FDA U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $250,000

## Abstract

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.

## Key facts

- **NIH application ID:** 11045885
- **Project number:** 1U01FD008266-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Carrie B Lee
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2024-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11045885

## Citation

> US National Institutes of Health, RePORTER application 11045885, Building Hybrid Operations to Promote Equity (HOPE) and improve clinical trial access across North Carolina (1U01FD008266-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11045885. Licensed CC0.

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