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Multiple‐arm superiority and non‐inferiority designs with various endpoints
Author(s) -
Chang Mark
Publication year - 2006
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.242
Subject(s) - sample size determination , statistic , statistics , binary number , mathematics , sample (material) , type i and type ii errors , contrast (vision) , computer science , arithmetic , artificial intelligence , chemistry , chromatography
Multiple‐arm dose–response superiority trials are widely studied for continuous and binary endpoints, while non‐inferiority designs have been studied recently in two‐arm trials. In this paper, a unified asymptotic formulation of a sample size calculation for k ‐arm ( k >0) trials with different endpoints (continuous, binary and survival endpoints) is derived for both superiority and non‐inferiority designs. The proposed method covers the sample size calculation for single‐arm and k ‐arm ( k ⩾2) designs with survival endpoints, which has not been covered in the statistic literature. A simple, closed form for power and sample size calculations is derived from a contrast test. Application examples are provided. The effect of the contrasts on the power is discussed, and a SAS program for sample size calculation is provided and ready to use. Copyright © 2006 John Wiley & Sons, Ltd.