Required efficacy for novel therapies in BCG‐unresponsive non‐muscle invasive bladder cancer: Do current recommendations really reflect clinically meaningful outcomes?

Background Single‐arm trials are currently an accepted study design to investigate the efficacy of novel therapies (NT) in non‐muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette‐Guérin (BCG) immunotherapy as randomized controlled trials are either unfeasible (comparator: early radical cystectomy; ERC), or unethical (comparator: placebo). To guide the design of such single‐arm trials, expert groups published...