Trials 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.
- Elaine Chang
- Andrea B. Apolo
- Matthew D. Galsky
