The heterogeneous nature of non-muscle-invasive bladder cancer is a challenge for clinical trial design. Careful consideration in clinical trial design, choice of end points and adequate patient characterization is important when evaluating new therapies.
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W.S.T. was a consultant to Combat Medical and research fellow and co-principal investigator for the HYMN and HIVEC-II trials. E.H. reports grants paid to their institution from Merck Sharpe & Dohme, Bayer, AstraZeneca, Accuray, Aventis Pharma, Varian Medical Systems, Janssen-Cilag and Roche. A.M.K. received grants from Adolor, BMS, FKD Industries, Heat Biologics, Janssen, Merck, Photocure, Seattle Genetics, Taris and SWOG; is on the board of and receives consulting fees from Asieris, Astellas, Biological Dynamics, BMS, CG Oncology, H3 Biomedicine, Eisai, Engene, FerGene, Imagin Medical, Incyte DSMB, Janssen, Medac, Merck, Photocure, ProTara, Roche, Seattle Genetics, Sessen Bio, Theralase, TMC Innovation, US Biotest and Urogen; has a joint patent for CyPRIT (Cytokine Predictors of Response to Intravesical Therapy) with UT MD Anderson Cancer Center; and is the President of the International Bladder Cancer Group (IBCG). J.D.K. was chief investigator for the HYMN and HIVEC-II trials, consultant to Combat Medical and is funded by the University College London Hospitals Biomedical Research Centre, Intuitive Surgical and The Urology Foundation.
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Tan, W.S., Hall, E., Kamat, A.M. et al. Clinical trial design for non-muscle-invasive bladder cancer. Nat Rev Urol 20, 575–576 (2023). https://doi.org/10.1038/s41585-023-00789-0
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DOI: https://doi.org/10.1038/s41585-023-00789-0