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One‐ and two‐stage designs for stratified phase II clinical trials
Author(s) -
London Wendy B.,
Chang Myron N.
Publication year - 2005
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.2139
Subject(s) - sample size determination , statistics , clinical trial , type i and type ii errors , stratified sampling , stage (stratigraphy) , test (biology) , log rank test , computer science , medicine , mathematics , survival analysis , paleontology , biology
A global one‐sample test for response rates for stratified phase II clinical trials is proposed. Such a test is analogous to that of a stratified log‐rank test for time‐to‐event data. Both one‐ and two‐stage tests are developed, and conditional and unconditional approaches are introduced in each case, where the conditional approach involves conditioning on the observed samples sizes within the strata. The methodology generates samples sizes and stopping boundaries that provide designs with the desired power and type I error probability. These methods are useful for designing stratified phase II clinical trials. An application to a Children's Oncology Group phase II clinical trial in relapsed neuroblastoma patients is presented. Copyright © 2005 John Wiley & Sons, Ltd.