Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop

Nature Reviews Urology, Published online: 10 September 2021; doi:10.1038/s41585-021-00505-wTrials evaluating novel therapies in the neoadjuvant setting must have clearly defined study elements and appropriately selected end points to ensure the applicability of the trial and enable interpretation of the study results. In this Perspectives, the authors describe the findings of a public workshop jointly sponsored by the US Food and Drug Administration and the Bladder Cancer Advocacy Network, which discussed key elements and end points when designing trials of neoadjuvant therapy for muscle-invasive bladder cancer.

Source: Nature Reviews Urology - September 10, 2021 Category: Urology & Nephrology Authors: Elaine Chang Andrea B. Apolo Rick Bangs Stephanie Chisolm Vinay Duddalwar Jason A. Efstathiou Kirsten B. Goldberg Donna E. Hansel Ashish M. Kamat Paul G. Kluetz Seth P. Lerner Elizabeth Plimack Tatiana Prowell Harpreet Singh Daniel Suzman Evan Y. Yu Hui Z Source Type: research