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Proper inference from Simon's two‐stage designs
Author(s) -
Koyama Tatsuki,
Chen Heidi
Publication year - 2007
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.3123
Subject(s) - inference , computer science , stage (stratigraphy) , econometrics , statistics , artificial intelligence , mathematics , biology , paleontology
Simon's two‐stage designs are very popular for phase II clinical trials. A literature review revealed that the inference procedures used with Simon's designs almost always ignore the actual sampling plan used. Reported P ‐values, point estimates and confidence intervals for the response rate are not usually adjusted for the design's adaptiveness. In addition, we found that the actual sample size for the second stage is often different from that planned. We present here a method for inferences using both the planned and the actual sample sizes. The conventional and the preferred inference procedures usually yield similar P ‐values and confidence intervals for the response rate. The conventional inference, however, may contradict the result of the corresponding hypothesis testing. Copyright © 2007 John Wiley & Sons, Ltd.