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Thomas Flaig, MD


Guidelines for Uniform Bladder Cancer Clinical Trials: A Collaborative Consensus

By: Amanda E. Ruffino, BA
Posted: Monday, January 8, 2024

Ashish M. Kamat, MD, MBBS, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues have recognized the pressing need for better therapies for urothelial cancer. Together with the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG), the investigators have assembled a diverse international panel of experts to provide essential recommendations for clinical trial designs in various urothelial cancer disease settings. These recommendations, published in the Journal of Clinical Oncology, aim to standardize approaches and foster advancements in drug development for bladder cancer.

The consensus panel employed a multidisciplinary approach, with the goal of offering guidance on critical aspects of clinical trials, including definitions of disease states, endpoints, trial design, evaluation methods, sample size calculations, and considerations related to pathology. The panel’s focus extended to multiple urothelial cancer scenarios.

Clinical trials for novel bladder cancer treatments should primarily aim to demonstrate their superiority over existing standards, since noninferiority trial designs can be complex and require large patient numbers because of subjective margins for unacceptable loss in efficacy, the authors noted. Key recommendations encompassed eligibility, design, endpoints, comparators, assessments, and sample size considerations across various bladder cancer disease states. In addition, they added, all trials for urothelial cancer should incorporate objective quality-of-life endpoints and consider the overall cost of treatment. Disease progression should be consistently counted as a recurrence event, and the diverse histologic features and subtypes within urothelial cancer should be accounted for in trial design, according to the investigators.

In closing, the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel’s work is expected to have a significant impact on the field of bladder cancer research and treatment. By offering clear and standardized guidelines for clinical trial designs across different urothelial cancer disease settings, these recommendations have the potential to enhance the consistency of research methodologies and ultimately accelerate the development of more effective therapies for patients with urothelial cancer.

Disclosure: For full disclosures of the study authors, visit

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