title: Some thoughts on the one-sided and two-sided tests.
abstract: This paper addresses some scientific and regulatory perspectives, insightful regulatory experiences, academic views, and current practices pertinent to one-sided and two-sided tests within the framework of clinical trials designed for specific diseases and drugs. It makes compelling points in favor of applying a two-sided test under a wide variety of situations. Additionally, it discusses situations where one may reasonably argue for use of a one-sided test and concludes by suggesting the use of two-sided tests in controversial situations.
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland.
authors.forename: S D
authors.initials: SD
authors.lastname: Dubey
mesh_terms: D001702:Biopharmaceutics / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D006801:Humans; D012107:Research Design / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration