Recent developments in oncology Phase 1 and Phase 2 studies
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*Anastasia Ivanova, UNC at Chapel Hill 

Keywords: phase 1, phase 2, dose-finding, ordinal tumor response, web-based software

We discuss novel statistical approaches to Phase 1 and 2 oncology clinical trials. Statistical challenges include dose-finding with delayed toxicity outcome, and Phase 2 studies with ordinal tumor response outcome and with time to event outcome. All new methods we discuss have been implemented in actual trials in the Lineberger Comprehensive Cancer Center. We have developed free, user-friendly web-based software for various methods discussed in this talk.