Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial.

Abstract

Objectives: In the United States, under-represented racial/ethnic groups lack ample enrollment in clinical trials, yielding ungeneralizable trial results. Barriers to increasing minority enrollment include decreased awareness of clinical trials, lack of access, financial burden and toxicity, medical system mistrust, and discordant physician-patient demographics.The ongoing Spine Patient Optimal Radiosurgery Treatment for Symptomatic MEtastatic Neoplasms (SPORTSMEN) clinical trial (NCT05617716 on clinicaltrials.gov) has a study design to actively accrue minority patients. We present our protocol addressing key targets to increase minority enrollment on this randomized, phase II clinical trial.

Methods: Adults with evidence of symptomatic spine metastases are eligible. Baseline demographics (including race/ethnicity) are reported for statistical analysis. Our protocol seeks to minimize barriers to minority enrollment and targets 5 key areas including clinical trial design, access to care, financial toxicity, community engagement, and patient-centered care.

Results and conclusions: Increasing clinical trial diversity is a challenge that must be addressed with meaningful intent to present robust level I data that broadens the understanding of treatment response in all demographics. Our protocol takes a patient-centered approach to achieve the objective of concordant racial/ethnic representation in a randomized clinical trial.