title: A note on the analysis of titration studies.
abstract: We propose a method to incorporate all types of dropouts in the evaluation of an intervention based on binary data from a titration study. The proposed procedure does not require that the dropouts occur randomly, but instead examines each outcome individually. Our procedure has a built-in penalty factor in the estimation process that determines the amount of penalty on efficacy parameters due to efficacy-related dropouts. We also propose a method to estimate the variances associated with the estimates. The results have use in exploration of a potential dose-response relationship or to answer questions pertinent for phase III studies. We use data from a phase III antihypertension study to illustrate the procedure.
authors.affiliation: Research Support Biostatistics Unit, Upjohn Company, Kalamazoo, MI 49001.
authors.forename: C
authors.initials: C
authors.lastname: Chuang-Stein
authors.forename: W J
authors.initials: WJ
authors.lastname: Shih
mesh_terms: D000465:Algorithms; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic / Q000379:methods; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D010349:Patient Compliance
chemical_list: D000959:Antihypertensive Agents