title: A new test of non-inferiority for anti-infective trials.
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.
authors.affiliation: Advanced Biologics LLC, 24 Arnett Avenue, Suite 100, Lambertville, NJ 08530, USA. phillips@advbiol.com
authors.forename: Kem F
authors.initials: KF
authors.lastname: Phillips
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic
chemical_list: D000890:Anti-Infective Agents