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Curtailed two‐stage designs with two dependent binary endpoints
Author(s) -
Chen ChiaMin,
Chi Yunchan
Publication year - 2011
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.496
Subject(s) - sample size determination , type i and type ii errors , clinical trial , binary number , stage (stratigraphy) , phase (matter) , computer science , phases of clinical research , statistics , maximum tolerated dose , reliability engineering , mathematics , medicine , arithmetic , biology , engineering , chemistry , paleontology , organic chemistry
When phase I clinical trials were found to be unable to precisely estimate the frequency of toxicity, Brayan and Day [1] proposed incorporating toxicity considerations into two‐stage designs in phase II clinical trials. Conaway and Petroni [2] further pointed out that it is important to evaluate the clinical activity and safety simultaneously in studying cancer treatments with more toxic chemotherapies in a phase II clinical trial. Therefore, they developed multi‐stage designs with two dependent binary endpoints. However, the usual sample sizes in phase II trials make these designs difficult to control the type I error rate at a desired level over the entire null region and still have sufficient power against reasonable alternatives. Therefore, the curtailed sampling procedure summarized by Phatak and Bhatt [3] will be applied to the two‐stage designs with two dependent binary endpoints in this paper to reduce sample sizes and speed up the development process for drugs. Copyright © 2011 John Wiley & Sons, Ltd.