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Activity Number: 35
Type: Contributed
Date/Time: Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304892
Title: Designs for Randomized Phase II Clinical Trials
Author(s): Myron Chang*+ and Wei Hou and Sin-Ho Jung and Yang Li
Companies: University of Florida and University of Florida and Duke University and University of Florida
Address: 1465 SW 88th St, Gainesville, FL, 32607, United States
Keywords: single-stage design ; two-stage design ; type I error rate ; power ; threshold ; average sample size

The primary objective of typical randomized phase II anti-cancer clinical trials is to evaluate experimental treatments that potentially will increase response rate over a historical baseline and select one to consider for further study. We propose single- and two-stage designs for randomized phase II clinical trials, precisely defining various type I error rates and powers in order to achieve this objective. We develop a program to compute these error rates and powers exactly, and we provide many design examples to satisfy prefixed requirements on error rates and powers. Finally, we apply our method to a randomized phase II trial in patients with relapsed non-Hodgkin's disease.

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