title: One-sided or two-sided p values: which most appropriately address the question of drug efficacy?
abstract: Whether a one-sided or a two-sided p value should be used for reporting the results of an analysis should be determined by the a priori question the investigation seeks to answer. It is concluded that one-sided p values are appropriate in clinical trials whose objective is to provide definitive, confirmatory evidence of efficacy of pharmaceutical compounds.
authors.affiliation: Biopharmaceutical Research Consultants, Inc., Ann Arbor, Michigan 48105.
authors.forename: K E
authors.initials: KE
authors.lastname: Peace
mesh_terms: D001702:Biopharmaceutics / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006801:Humans; D012107:Research Design / Q000706:statistics & numerical data*