Dedicated research navigators: a tool to decrease disparities in clinical trial enrollment?

Area of Science:

• Oncology
• Clinical Trials
• Health Equity

Background:

• Racial disparities exist in clinical trial enrollment, potentially impacting treatment outcomes.
• Tertiary academic centers face challenges in ensuring equitable access to clinical trials for diverse patient populations.

Purpose of the Study:

• To assess the impact of a formalized research team and screening process on racial disparities in clinical trial enrollment.
• To evaluate the effectiveness of a dedicated research navigator team in a gynecologic oncology setting.

Main Methods:

• Retrospective cohort study of patients with gynecologic malignancies approached for clinical trial enrollment (March 2018-February 2022).
• Implementation of a dedicated research navigator team and protocol for patient screening and approach.
• Comparison of enrollment rates and demographic data between a control group (pre-navigator) and the research navigator team group.

Main Results:

• The research navigator team increased clinical trial enrollment from 15.0% to 36.9%.
• Minority inclusion was high, with 27.3% of patients being Black.
• Patients with recurrent disease were more likely to enroll than those with primary disease (p < .001).
• Top reasons for declining trials included preference for local treatment (25.0%) and concerns about the trial (21.7%).

Conclusions:

• A dedicated research navigator team effectively increased eligible patient identification and reduced racial disparities in clinical trial enrollment.
• Addressing patient preferences for local treatment is crucial for improving trial participation.
• Continued efforts to identify and overcome barriers are essential for enhancing outcomes in gynecologic oncology clinical trials.