ArticleBMC cancer2026
Eligibility criteria and study phase limit racial/ethnic enrollment in oncology clinical trials.
Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundRacial/ethnic minority enrollment in oncological therapeutic clinical trials (TCT) remains low. Thus, we explored whether TCTs' restrictiveness enrollment criteria and phase were associated with racial/ethnic minority enrollment.
methodsWe analyzed cross-sectional (2016-2023) enrollment data and protocols from oncology TCTs completed at a large urban medical research institution. Two reviewers assessed eligibility restrictiveness using ASCO and Friends of Cancer Research recommendations. Trials received a score (0-8) based on criteria related to brain metastases, infectious diseases (HIV, hepatitis B/C), organ dysfunction (cardiac, liver, kidney), and prior or concurrent malignancies; those with scores above the 75th percentile were classified as restrictive (score > 4). Trial phase was categorized as early (I/II) or late (III/IV). Participants (n = 876) from 144 TCTs were classified as minority (Hispanic, Black, American Indian/Alaska Native, Native Hawaiian/Pacific Islander) or non-minority per NIH definitions. Multivariable Poisson GEE models, adjusting for age, sex, trial timing relative to ASCO/Friends recommendations, and sponsor type, explore these associations.
resultsCompleted TCTs were most restrictive in excluding patients with a prior or concurrent malignancy(73%), HIV(59%), and/or liver dysfunction(53%). Of the 876 trial participants, 32% were racial/ethnic minorities, and only 17% were enrolled in restrictive TCTs. Restrictive TCTs had 31%(RR=0.69, 95%CI=0.50-0.95) and early-phase TCTs had 34%(RR =0.66, 95%CI=0.52-0.78) lower risk of enrolling racial/ethnic minority participants compared to standard and later-phase TCTs, respectively.
conclusionsTCT studies with restrictive enrollment eligibility criteria and early-phase studies were less likely to enroll racial/ethnic minority participants. Underscoring that enrollment eligibility criteria is a barrier that may hinder minority enrollment.
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