Contrasting reasons for early termination between industry and non-industry-led clinical trials in genitourinary oncology.

OBJECTIVE

To compare reasons for early termination among genitourinary oncology trials by sponsor type, such as academic- vs. industry-sponsored.

METHODS

We conducted a retrospective, registry-based study of interventional Phase II-III genitourinary oncology trials reported on ClinicalTrials.gov from 2005-2025. Trials were categorized according to registry-defined lead sponsor designations (industry vs non-industry). Industry-sponsored trials were stratified by company size. The primary outcome was early termination, while the secondary outcome was reason for termination. Odds ratios were estimated using logistic regression, followed by multivariable multinomial logistic regression to model termination reasons by sponsor type.

RESULTS

Among 1,597 included trials, 33.1% were industry-sponsored. Early termination occurred in 27.9% of trials, with no difference by sponsor type (26.1% vs 28.8%). Poor accrual was the leading cause among non-industry-sponsored trials (54.4%), whereas sponsor or strategic decisions predominated among industry-sponsored trials (32.6%). Relative to poor accrual, industry sponsorship was associated with sponsor or strategic decisions (aOR 9.12, 95% CI 3.58-23.23; p < 0.001), regulatory or administrative barriers (aOR 24.36, 95% CI 5.22-113.57; p < 0.001), and interim futility or efficacy findings (aOR 3.31, 95% CI 1.21-9.06; p = 0.020). Large pharmaceutical sponsors achieved higher completion rates than smaller sponsors (84.5% vs 67.8%, p < 0.001) with subtle differences in termination patterns.

CONCLUSIONS

Over one in four genitourinary oncology trials end prematurely, most commonly from accrual or sponsor-related causes. Academic-led studies are mainly limited by recruitment challenges, whereas industry-led discontinuations are often strategic. Strengthening accrual infrastructure may reduce premature trial failure and improve research efficiency.