title: Dose finding with the sequential parallel comparison design.
abstract: The sequential parallel comparison design (SPCD) is a two-stage design recommended for trials with possibly high placebo response. A drug-placebo comparison in the first stage is followed in the second stage by placebo nonresponders being re-randomized between drug and placebo. We describe how SPCD can be used in trials where multiple doses of a drug or multiple treatments are compared with placebo and present two adaptive approaches. We detail how to analyze data in such trials and give recommendations about the allocation proportion to placebo in the two stages of SPCD.
authors.affiliation: a Department of Biostatistics , University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
authors.forename: Jessie J
authors.initials: JJ
authors.lastname: Wang
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
mesh_terms: D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D015990:Placebo Effect; D010919:Placebos / Q000008:administration & dosage*; D011336:Probability; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design
chemical_list: D004364:Pharmaceutical Preparations; D010919:Placebos
keywords: Adaptive design; Dose-finding; Phase 2; Placebo response; SPCD; Sequential parallel comparison design