Journal article
Practical Model-Based Dose Finding in Early-Phase Clinical Trials
Abstract
BACKGROUND AND PURPOSE: A safe and effective tissue plasminogen activator (tPA) dose for childhood stroke has not been established. This article describes a Bayesian outcome-adaptive method for determining the best dose of an experimental agent and explains how this method was used to design a dose-finding trial for tPA in childhood.
METHODS: The method assigns doses to successive cohorts of patients on the basis of each dose's desirability, …
Authors
Whelan HT; Cook JD; Amlie-Lefond CM; Hovinga CA; Chan AK; Ichord RN; deVeber GA; Thall PF
Journal
Stroke, Vol. 39, No. 9, pp. 2627–2636
Publisher
Wolters Kluwer
Publication Date
September 2008
DOI
10.1161/strokeaha.107.510164
ISSN
0039-2499
Associated Experts
Fields of Research (FoR)
Medical Subject Headings (MeSH)
AdolescentAge FactorsBayes TheoremBrain IschemiaChildChild, PreschoolClinical ProtocolsClinical Trials as TopicCohort StudiesComputer SimulationDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFibrinolytic AgentsHumansInfantModels, StatisticalResearch DesignStrokeTissue Plasminogen ActivatorTreatment Outcome