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

Abstract

Objective: The goal of this study was to evaluate the impact of a formalized research team and screening process on racial disparities associated with clinical trial enrollment at a tertiary academic center.

Methods: We conducted a retrospective cohort study of patients with gynecologic malignancies approached for clinical trial enrollment from March 2018 to February 2022. A dedicated research navigator team and protocol were implemented to review and approach all (potentially) eligible clinical trial patients. The control group consisted of patients enrolled prior to the research navigator team. A survey was also performed in the research navigator team group to evaluate the reasons why patients decline clinical trials. Analysis was performed using SPSS version 26.

Results: A total of 411 patients were included in this cohort with 187 in the control group and 224 in the research navigator team. There was a high rate of minority inclusion with 27.3% of patients being Black. Enrollment in the clinical trials increased from 15.0% to 36.9% after the initiation of the research navigator team. Patients were more likely to enroll if they had recurrent disease vs primary disease (p < .001). The most common reasons for patients declining clinical trials were the desire to receive treatment locally (25.0%), concern about the trial (21.7%), and wanting to receive the standard of care treatment (15.0%).

Conclusions: Using a dedicated research navigator team increased the identification of eligible patients and decreased racial disparities in clinical trial enrollment at our tertiary academic center. The most common reason women declined enrollment was to receive treatment locally. Continued identification of barriers to trial enrollment remains paramount in working to improve outcomes for gynecologic oncology patients.