Document Detail


Designing group sequential randomized clinical trials with time to event end points using a R function.
MedLine Citation:
PMID:  22405523     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
A major and difficult task is the design of clinical trials with a time to event endpoint. In fact, it is necessary to compute the number of events and in a second step the required number of patients. Several commercial software packages are available for computing sample size in clinical trials with sequential designs and time to event endpoints, but there are a few R functions implemented. The purpose of this paper is to describe features and use of the R function. plansurvct.func, which is an add-on function to the package gsDesign which permits in one run of the program to calculate the number of events, and required sample size but also boundaries and corresponding p-values for a group sequential design. The use of the function plansurvct.func is illustrated by several examples and validated using East software.
Authors:
Thomas Filleron; Jocelyn Gal; Andrew Kramar
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-7
Journal Detail:
Title:  Computer methods and programs in biomedicine     Volume:  -     ISSN:  1872-7565     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-12     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8506513     Medline TA:  Comput Methods Programs Biomed     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Affiliation:
Institut Claudius Régaud, 20-24 rue du Pont Saint Pierre, 31052 Toulouse, France.
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