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A new test of non‐inferiority for anti‐infective trials
Author(s) -
Phillips Kem F.
Publication year - 2002
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.1122
Subject(s) - statistics , test (biology) , type i and type ii errors , mathematics , statistical hypothesis testing , statistical power , econometrics , range (aeronautics) , medicine , computer science , paleontology , materials science , composite material , biology
This paper describes a new statistical test of non‐inferiority in clinical trials of anti‐infective medications. The test allows the inferiority limit, delta, to vary with the underlying success rates. The test is a simple modification of the standard fixed‐delta test, and its parameters can be adjusted to yield the fixed‐delta test, a test similar to the FDA's Points‐to‐Consider procedure, or a test with nearly constant power values over a range of success rates. The test satisfies the size and power criteria for a valid statistical test. The effects on the test of lowering success rates through stringent criteria or through error are discussed. Copyright © 2002 John Wiley & Sons, Ltd.