title: Superior safety in noninferiority trials.
abstract: Noninferiority of a new treatment to a reference treatment with respect to efficacy is usually associated with the superiority of the new treatment to the reference treatment with respect to other aspects not associated with efficacy. When the superiority of the new treatment to the reference treatment is with respect to a specified safety variable, it may be necessary to perform the between-treatment comparisons. The efficacy and safety comparisons may be considered separately or simultaneous comparisons may be performed. Here techniques are discussed for the simultaneous consideration of both aspects.
authors.affiliation: Purdue Pharma LP, Cranbury, New Jersey, USA. drbris@msn.com
authors.forename: David R
authors.initials: DR
authors.lastname: Bristol
mesh_terms: D001702:Biopharmaceutics / Q000379:methods; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D004341:Drug Evaluation; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012106:Research; D013810:Therapeutic Equivalency