Improving access to therapeutic clinical trials: a randomized controlled trial of GUIDE navigation and reimbursement - Report - MDSpire

Improving access to therapeutic clinical trials: a randomized controlled trial of GUIDE navigation and reimbursement

  • By

  • Kristine A. Karvonen

  • Jean A. McDougall

  • Elizabeth A. Carosso

  • Tina Burrows

  • Solange H. Mecham

  • Chongzhi Di

  • Sarah D. Hohl

  • Elizabeth Stohr

  • Anne Devine

  • Hannah Linden

  • Ajay K. Gopal

  • Evan Y. Yu

  • Andrew J. Cowan

  • Jason A. Mendoza

  • June 16, 2026

  • 0 min

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Clinical Report: Enhancing Access to Cancer Clinical Trials with GUIDE

Overview

The GUIDE program, a clinical trial navigation initiative, aims to improve access to cancer clinical trials for socioeconomically disadvantaged populations by providing financial support and navigation services. This pilot randomized controlled trial evaluates the program's effectiveness in increasing enrollment, retention, and patient trust while addressing health-related social needs.

Background

Disparities in access to cancer clinical trials significantly affect socioeconomically disadvantaged populations, leading to underrepresentation and reduced generalizability of trial results. Clinical trial navigation programs have emerged as potential solutions to these disparities, yet their components and effectiveness remain poorly understood. The GUIDE program seeks to address these gaps by combining financial reimbursement for trial-related expenses with navigation services.

Data Highlights

No numerical data available in the provided material.

Key Findings

  • The GUIDE program focuses on financial reimbursement and navigation services for cancer clinical trial participants.
  • It aims to reduce barriers related to health-related social needs, such as transportation and housing.
  • The program is being evaluated through a pilot randomized controlled trial involving 100 adults with cancer.
  • Previous studies indicate that navigation programs can improve clinical trial enrollment and retention.
  • Effective navigation programs may enhance patient satisfaction and reduce overall healthcare costs.

Clinical Implications

Healthcare professionals should consider implementing navigation programs like GUIDE to improve access to clinical trials for underrepresented populations. Addressing financial and social barriers can enhance patient participation and potentially improve trial outcomes.

Conclusion

The GUIDE program represents a promising approach to enhancing access to cancer clinical trials for socioeconomically disadvantaged patients. Continued evaluation of its effectiveness will provide insights into the best practices for clinical trial navigation.

Related Resources & Content

  1. The ASCO Post, 2022 -- Can a Navigation Program Lower Care Costs for Patients With Cancer?
  2. The ASCO Post, 2018 -- Actively Recruiting Clinical Trials Focused on Cancer Prevention
  3. The ASCO Post, 2014 -- Ongoing NCI-Funded Clinical Trials Actively Recruiting Patients With Advanced Cancer
  4. The ASCO Post, 2023 -- How Patient Navigation Programs Are Helping Drive Equitable Care for Patients With Cancer and Improve Outcomes
  5. FDA -- Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
  6. ASCO State of Cancer Care in America Special Report 2025: Access to Cancer Clinical Trials in the United States | JCO Oncology Practice
  7. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies | FDA
  8. ASCO State of Cancer Care in America Special Report 2025: Access to Cancer Clinical Trials in the United States | JCO Oncology Practice

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