title: A simulation study used to design the sequential monitoring plan for a clinical trial.
abstract: In designing a sequential monitoring plan for the AVID (Antiarrhythmics Versus Implantable Defibrillators) study, a multi-centred clinical trial, we completed a simulation study to help ourselves and the Data Safety Monitoring Board understand the implications of various monitoring plans. In particular, we compared three test statistics and three use functions. Simulation was based on approximate trial parameters and two plausible but distinct alternative hypotheses. The power to detect a difference between the two treatment arms was computed as a function of time. The simulated results illuminate several of the important statistical and ethical issues involved in selecting a sequential monitoring plan and illustrate how one can use simulations to design a clinical trial.
authors.affiliation: AVID Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle 98105, USA.
authors.forename: M M
authors.initials: MM
authors.lastname: Brooks
authors.forename: A
authors.initials: A
authors.lastname: Hallstrom
authors.forename: M
authors.initials: M
authors.lastname: Peckova
mesh_terms: D000638:Amiodarone / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D003198:Computer Simulation; D003657:Decision Making; D017147:Defibrillators, Implantable; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015203:Reproducibility of Results; D012107:Research Design; D013015:Sotalol / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000628:therapy; D013997:Time Factors; D014693:Ventricular Fibrillation / Q000628:therapy
chemical_list: D000889:Anti-Arrhythmia Agents; D013015:Sotalol; D000638:Amiodarone