title: A bootstrap-based test for establishing noninferiority in clinical trials.
abstract: A randomized, active-control clinical trial setting with the objective of testing noninferiority for a continuous response variable is considered. Noninferiority margin is based on the concept of preserving a certain fraction of the active control effect. Noninferiority is established if the ratio of the lower (upper) limit of the two-sided 95% confidence interval for the treatment difference to the estimated mean of the active control is greater (less) than a certain fraction. The nominal significance level is not maintained by the above confidence interval-based noninferiority test. We use bootstrapping to derive an accurate lower (upper) limit of the same confidence interval, which approximates the nominal significance level better and improves the power.
authors.affiliation: Biometrics, US Clinical Development and Medical Affairs, Novartis Pharmaceuticals, East Hanover, NJ 07936, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Chen
authors.forename: Farid
authors.initials: F
authors.lastname: Kianifard
authors.forename: Sunil K
authors.initials: SK
authors.lastname: Dhar
mesh_terms: D003198:Computer Simulation; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design