Linked Life Data

12947355

Source:http://linkedlifedata.com/resource/pubmed/id/12947355

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2003-8-29
pubmed:abstractText
The randomized, double-blind, placebo-controlled trial is the optimum method for clinical evaluation of new treatments, as assessed by clinicians and statisticians. However, if a known standard of therapy exists, it may be difficult to prove that a new therapy is superior. Equivalence and noninferiority clinical trial designs are now frequently utilized in clinical medical research. This article reviews the statistical differences between superiority, equivalence, and noninferiority design schemes, which pose specific ethical questions and have important implications for interpretation and clinical application of trial results. A guideline is proposed as a standard approach for reporting to facilitate qualitative assessment of the methodology of these trials.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
1097-6744
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
146
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
398-403
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2003
pubmed:articleTitle
Active-control clinical trials to establish equivalence or noninferiority: methodological and statistical concepts linked to quality.
pubmed:affiliation
Rush Heart Institute for Pulmonary Heart Disease, Rush School of Medicine, Chicago, Ill 60612-3824, USA. Mardi_Gomberg@rush.edu
pubmed:publicationType
Journal Article