title: Software to compute and conduct sequential Bayesian phase I or II dose-ranging clinical trials with stopping rules.
abstract: The aim of dose-ranging phase I (resp. phase II) clinical trials is to rapidly identify the maximum tolerated dose (MTD) (resp., minimal effective dose (MED)) of a new drug or combination. For the conduct and analysis of such trials, Bayesian approaches such as the Continual Reassessment Method (CRM) have been proposed, based on a sequential design and analysis up to a completed fixed sample size. To optimize sample sizes, Zohar and Chevret have proposed stopping rules (Stat. Med. 20 (2001) 2827), the computation of which is not provided by available softwares. We present in this paper a user-friendly software for the design and analysis of these Bayesian Phase I (resp. phase II) dose-ranging Clinical Trials (BPCT). It allows to carry out the CRM with stopping rules or not, from the planning of the trial, with choice of model parameterization based on its operating characteristics, up to the sequential conduct and analysis of the trial, with estimation at stopping of the MTD (resp. MED) of the new drug or combination.
authors.affiliation: Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, AP-HP, Université Paris 7, U444-INSERM, Paris Cedex, France. szohar@chu-stlouis.fr
authors.forename: Sarah
authors.initials: S
authors.lastname: Zohar
authors.forename: Aurelien
authors.initials: A
authors.lastname: Latouche
authors.forename: Mathieu
authors.initials: M
authors.lastname: Taconnet
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
mesh_terms: D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D018401:Sample Size; D012984:Software
chemical_list: D004364:Pharmaceutical Preparations