Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2002-12-30
pubmed:abstractText
Sample size determination in randomized clinical trials usually relies on the determination of survival rates at the time of analysis in both groups, under the null and the alternative hypotheses, the type I and II error rates and on other assumptions, such as proportional hazards in most cases. However, in numerous clinical trials for malignant chronic diseases, it is currently common that a patient allocated to the conventional treatment group would receive the experimental treatment in case of disease progression or relapse. Such crossovers are usually not taken into account when computing the sample size of the trial, but generally result in a decreased power of the trial. In this work, we aimed to correct the sample size of such trials to control the power, under an exponential survival assumption.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0197-2456
pubmed:author
pubmed:issnType
Print
pubmed:volume
23
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
650-61
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2002
pubmed:articleTitle
Sample size correction for treatment crossovers in randomized clinical trials with a survival endpoint.
pubmed:affiliation
Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris, France. raphael.porcher@chu-stlouis.fr
pubmed:publicationType
Journal Article