Document Detail


Software to compute and conduct sequential Bayesian phase I or II dose-ranging clinical trials with stopping rules.
MedLine Citation:
PMID:  12941516     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Sarah Zohar; Aurelien Latouche; Mathieu Taconnet; Sylvie Chevret
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Computer methods and programs in biomedicine     Volume:  72     ISSN:  0169-2607     ISO Abbreviation:  Comput Methods Programs Biomed     Publication Date:  2003 Oct 
Date Detail:
Created Date:  2003-08-27     Completed Date:  2004-03-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8506513     Medline TA:  Comput Methods Programs Biomed     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  117-25     Citation Subset:  IM    
Affiliation:
Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, AP-HP, Université Paris 7, U444-INSERM, Paris Cedex, France. szohar@chu-stlouis.fr
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MeSH Terms
Descriptor/Qualifier:
Bayes Theorem*
Clinical Trials, Phase I as Topic / statistics & numerical data*
Clinical Trials, Phase II as Topic / statistics & numerical data*
Dose-Response Relationship, Drug
Humans
Models, Statistical*
Pharmaceutical Preparations / administration & dosage*
Sample Size
Software*
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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