Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2000-7-11
pubmed:abstractText
This paper presents an overview of recent developments in statistical methods for the design of clinical trials. Whilst the methods are suitable for application in a wide range of therapeutic areas, they are of particular value in intensive care medicine due to its high levels of mortality and short periods of follow-up. The paper reviews the calculation of the sample size necessary to achieve a given power requirement, and then describes the operation of a Data and Safety Monitoring Board, the mid-trial reassessment of sample size and the use of stopping rules to terminate a study as soon as sufficient evidence is available. The purpose of the paper is to encourage investigators to consider the wide range of design options which have recently become available, when planning a new clinical study.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
0342-4642
pubmed:author
pubmed:issnType
Print
pubmed:volume
26 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
S84-8
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Monitoring and evaluating clinical trials data.
pubmed:affiliation
MPS Research Unit, The University of Reading, Earley Gate, UK. j.r.whitehead@reading.ac.uk
pubmed:publicationType
Journal Article