Testing non-inferiority and superiority for two endpoints for several treatments with a control.
Some multiple comparison procedures are described for multiple armed studies. The procedures are appropriate for testing all hypotheses for comparing two endpoints and multiple test arms to a single control group, for example three different fixed doses compared to a placebo. The procedure assumes that among the two endpoints, one is designated as a primary endpoint such that for a given treatment arm, no hypothesis for the secondary endpoint can be rejected unless the hypothesis for the primary endpoint was rejected. The procedures described control the family-wise error rate in the strong sense at a specified level α.
Lawrence
John
J
US Food and Drug Administration, Silver Spring, MD 20993-002, USA. John.Lawrence@fda.hhs.gov
D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012107:Research Design
D004364:Pharmaceutical Preparations