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Sample size determination for clinical trials with co‐primary outcomes: exponential event times
Author(s) -
Hamasaki Toshimitsu,
Sugimoto Tomoyuki,
Evans Scott,
Sozu Takashi
Publication year - 2012
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.1545
Subject(s) - sample size determination , clinical trial , event (particle physics) , statistics , medicine , randomized controlled trial , mathematics , physics , quantum mechanics
Clinical trials with event‐time outcomes as co‐primary contrasts are common in many areas such as infectious disease, oncology, and cardiovascular disease. We discuss methods for calculating the sample size for randomized superiority clinical trials with two correlated time‐to‐event outcomes as co‐primary contrasts when the time‐to‐event outcomes are exponentially distributed. The approach is simple and easily applied in practice. Copyright © 2012 John Wiley & Sons, Ltd.