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The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
FDA published guidance on November 17, 2016 to assist pharmaceutical companies in the clinical development of treatments for patients with bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer. The guidance discusses the pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints.
The guidance, which may also apply to the development of drugs for other forms of nonmuscle invasive bladder cancer, addresses early and late-phase development and other considerations such as risk management and nonclinical safety. Statistical analysis and clinical trial design are not covered in the guidance. For those topics, FDA recommends sponsors follow International Council for Harmonization (ICH) guidelines E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.