Designs for randomized phase II clinical trials with two treatment arms.

Journal Article (Journal Article)

The most common primary statistical end point of a phase II clinical trial is the categorization of a patient as either a 'responder' or 'nonresponder'. The primary objective of typical randomized phase II anticancer 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-stage and two-stage designs for randomized phase II clinical trials, precisely defining various type I error rates and powers to achieve this objective. We develop a program to compute these error rates and powers exactly, and we provide many design examples to satisfy pre-fixed 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.

Full Text

Duke Authors

Cited Authors

  • Hou, W; Chang, MN; Jung, S-H; Li, Y

Published Date

  • November 10, 2013

Published In

Volume / Issue

  • 32 / 25

Start / End Page

  • 4367 - 4379

PubMed ID

  • 23630064

Electronic International Standard Serial Number (EISSN)

  • 1097-0258

Digital Object Identifier (DOI)

  • 10.1002/sim.5829


  • eng

Conference Location

  • England