American Statistical Association New York City Metropolitan Area Chapter Memorial Sloan-Kettering Cancer Center Biostatistics Seminar

I will present a review of recently developed phase II clinical trials. Phase II trials are a critical step in drug development and the majority of trials we design at MSK. The goal of these studies is to evaluate efficacy of a drug/regimen for a particular type of tumor. In the past decade, the development of molecularly targeted agents has triggered a debate as to the optimal design of phase II studies in oncology. The Clinical Trial Design Task Force (CTD-TF) of the NCI Investigational Drug Steering Committee has published recommendations that encourage the use of newer designs rather than the traditional single arm phase II clinical trial that is typically implemented. This review will provide an overview and summarize the options for Phase II trial designs.