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Urothelial cancer clinical trials tended to be small, identical between institutions
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Most clinical trials for muscle-invasive and metastatic urothelial cancer were small, single-arm, phase 2 trials that involved one to three study sites and exhibited slow patient accrual, according to recent results.
In addition, researchers identified several instances in which nearly identical trials were being performed by separate institutions.
Matthew D. Galsky
To assess current trends in urothelial cancer research and evaluate opportunities to make best use of successful drug development, Matthew D. Galsky, MD, assistant professor of urology at Mount Sinai Hospital, and colleagues performed a search of the ClinicalTrials.gov registry for clinical trials designed to explore interventions in muscle-invasive and metastatic urothelial cancer.
Data obtained from the registry included title, recruitment status, sponsor, phase, enrollment, study design interventions and study sites.
Of the 120 eligible trials currently investigating interventions in muscle-invasive and metastatic urothelial cancer, 73% were identified as phase 2 and 73% were nonrandomized, Galsky and colleagues found.
In addition, the researchers observed that 63% of eligible trials concerned treatment in the metastatic disease state and 55% involved three study sites or fewer. The typical planned enrollment size per trial was approximately 45 patients, with most trials investigating interventions in first-line metastatic (30%) or second-line metastatic (37%) settings.
“Barriers such as insufficient funding and accrual concerns have driven patient resources into small, nonrandomized, single-center trials that are generally not designed, nor intended, to immediately advance current care standards,” Galsky and colleagues wrote.
Among 56 trials that completed enrollment, the median time to complete accrual was 50 months (range, 10-109 months). These trials enrolled a median of 40 patients per trial (interquartile range, 44 patients).
“We cannot afford to let our lack of communication and collaboration be among the many barriers to the development of more effective therapies in urothelial cancer,” Galsky and colleagues wrote. “Fortunately, there are many recent examples of enhanced cooperation in clinical research in this disease. Ultimately, additional disease-specific research networks, or consortia, are needed to make progress for our patients as expeditiously as possible.”
Disclosure: The researchers report no relevant financial disclosures.
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