title: A mixture gatekeeping procedure based on the Hommel test for clinical trial applications.
abstract: When conducting clinical trials with hierarchically ordered objectives, it is essential to use multiplicity adjustment methods that control the familywise error rate in the strong sense while taking into account the logical relations among the null hypotheses. This paper proposes a gatekeeping procedure based on the Hommel (1988) test, which offers power advantages compared to other p value-based tests proposed in the literature. A general description of the procedure is given and details are presented on how it can be applied to complex clinical trial designs. Two clinical trial examples are given to illustrate the methodology developed in the paper.
authors.affiliation: Dainippon Sumitomo Pharma Co., Ltd., Suita, Osaka 564-0053, Japan. thomas_brechenmacher@hotmail.com
authors.forename: Thomas
authors.initials: T
authors.lastname: Brechenmacher
authors.forename: Jane
authors.initials: J
authors.lastname: Xu
authors.forename: Alex
authors.initials: A
authors.lastname: Dmitrienko
authors.forename: Ajit C
authors.initials: AC
authors.lastname: Tamhane
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy; D015233:Models, Statistical; D011336:Probability; D012559:Schizophrenia / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D014150:Antipsychotic Agents