A new test of non‐inferiority for anti‐infective trials
- 12 July 2002
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 22 (2), 201-212
- https://doi.org/10.1002/sim.1122
Abstract
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.Keywords
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