Impact of Industry Collaboration on US Food and Drug Administration Approval Success in Genitourinary Malignancy Phase III Clinical Trials.

Abstract

Purpose: Collaboration among trial sponsors can pool expertise and resources, potentially accelerating drug development and regulatory success. This study assessed whether collaborations between drug sponsors influence the likelihood and timing of US Food and Drug Administration (FDA) approval for phase III clinical trials in genitourinary cancers.

Methods: We queried ClinicalTrials.gov for all industry-sponsored, interventional phase III trials in genitourinary malignancies completed between January 1, 2010, and October 1, 2024. Trials involving supportive agents, nontherapeutics, or bioequivalence studies were excluded. Eligible trials were grouped by sponsorship structure: single-sponsor (SS) or sponsor-collaborator (S-C). Time to FDA approval was compared using Kaplan-Meier estimates and log-rank tests. Stratified Cox regression assessed the impact of collaboration across subgroups (disease site, stage, and previous drug approval). An additional analysis examined trials that met their primary end points.

Results: Seventy-eight trials met inclusion criteria from an initial 183. Of these, 51 (65.4%) were SS trials and 27 (34.6%) were S-C. FDA approval was granted for 20 of 27 S-C trials (74.1%) versus 20 of 51 SS trials (39.2%). S-C trials had significantly faster approval (hazard ratio [HR], 2.75 [95% CI, 1.46 to 5.18]; P = .0009). One- and 2-year approval rates were, respectively, 50.0% and 73.6% for S-C, compared with 19.6% and 31.4% for SS trials. Subgroup analyses confirmed consistent benefits across metastatic disease, prostate cancer, and previously approved drugs. Among the 50 trials that met their primary end points, S-C trials had a higher approval likelihood (HR, 2.23 [95% CI, 1.13 to 4.38]; P = .013).

Conclusion: Sponsor collaboration significantly improves FDA approval rates and timelines in phase III genitourinary cancer trials, including those meeting primary end points. This strategy may enhance trial success and accelerate access to new therapies.