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Selection and Prejudice: Addressing Clinical Trial Disparities With a Review of Current Shortcomings and Future
Kelsey L Corrigan1, Michael K Rooney1, Ramez Kouzy1
1Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Abstract:
Growing evidence has demonstrated significant, persistent, and widespread disparities in cancer clinical trial enrollment across myriad disease sites and target populations. Although mechanisms underlying such disparities are complex and multifactorial, clinical trial eligibility criteria may serve as a key structural barrier to equitable and diverse trial enrollment. In this review, we provide an overview of the data describing historical and current disparities in cancer clinical trial enrollment and subsequently describe several patient-, institution-, and trial-related factors which appear to be key drivers of enrollment inequity, with specific discussion regarding the impact of eligibility criteria. We further describe the landscape of ongoing professional efforts aimed at eliminating clinical trial disparities through various medical, professional, and advocacy groups. The review concludes with a practical discussion of how modernization of eligibility criteria in clinical trials may decrease or eliminate trial disparities, including specific actionable recommendations aimed at improving the quality of future eligibility criteria.
Insights
Cancer clinical trial enrollment disparities persist due to complex factors, including restrictive eligibility criteria. Modernizing these criteria is crucial for improving equitable access to cancer research and treatment for all patients.
Area of Science:
- Oncology
- Clinical Trials
- Health Equity
Background:
- Significant and persistent disparities exist in cancer clinical trial enrollment across diverse populations and disease sites.
- These inequities limit the generalizability of trial findings and hinder progress in cancer care.
Purpose of the Study:
- To review current data on cancer clinical trial enrollment disparities.
- To identify key patient-, institution-, and trial-related factors driving these inequities, focusing on eligibility criteria.
- To discuss ongoing professional efforts and propose actionable recommendations for modernizing eligibility criteria to enhance trial diversity.
Main Methods:
- Literature review synthesizing data on cancer clinical trial enrollment disparities.
- Analysis of factors contributing to enrollment inequity, with emphasis on eligibility criteria.
- Examination of current initiatives and proposed strategies for improving trial diversity.
Main Results:
- Eligibility criteria represent a significant structural barrier to equitable cancer clinical trial enrollment.
- Multiple patient, institutional, and trial-specific factors contribute to enrollment disparities.
- Ongoing professional efforts aim to address these inequities.
Conclusions:
- Modernizing clinical trial eligibility criteria is a critical actionable step towards reducing disparities.
- Implementing updated criteria can improve the quality and representativeness of cancer clinical trials.
- Equitable trial enrollment is essential for advancing cancer research and patient outcomes.
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