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Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation
Ulysses G Gardner1, Otis W Brawley2, Elizabeth E Obi3
1Department of Radiation Oncology and Molecular Sciences.
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.
Insights
Clinical trial diversity is crucial for generalizable results. This protocol targets barriers to minority enrollment in the SPORTSMEN trial, aiming for equitable representation in cancer research.
Area of Science:
- Oncology
- Clinical Trial Design
- Health Equity
Background:
- Under-represented racial/ethnic groups have limited enrollment in U.S. clinical trials, leading to results that are not generalizable to diverse populations.
- Barriers to minority enrollment include lack of awareness, access issues, financial burden, mistrust in the medical system, and demographic discordance between physicians and patients.
Purpose of the Study:
- To present a protocol designed to actively increase minority patient enrollment in the Spine Patient Optimal Radiosurgery Treatment for Symptomatic MEtastatic Neoplasms (SPORTSMEN) clinical trial (NCT05617716).
- To address key targets for enhancing minority participation in a randomized, phase II clinical trial for symptomatic spine metastases.
Main Methods:
- The study includes adult patients with symptomatic spine metastases.
- A protocol is detailed to minimize barriers to minority enrollment, focusing on five key areas: clinical trial design, access to care, financial toxicity, community engagement, and patient-centered care.
- Baseline demographics, including race/ethnicity, will be collected for statistical analysis.
Main Results:
- The protocol aims to achieve concordant racial/ethnic representation within the SPORTSMEN clinical trial.
- Focus on patient-centered strategies to overcome enrollment barriers for diverse populations.
Conclusions:
- Increasing clinical trial diversity is essential for generating robust evidence applicable to all demographic groups.
- A patient-centered approach is vital for achieving equitable racial/ethnic representation in randomized clinical trials.
- This protocol offers a framework for improving minority participation in cancer clinical trials.
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