Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2003-10-30
pubmed:abstractText
In simultaneous testing for noninferiority and superiority, Morikawa and Yoshida (Morikawa, T., Yoshida, M. (1995). A useful testing strategy in phase III trails: Combined test of superiority and test of equivalence. J. Biopharmaceutical Statistics 5:297-306) argue that multiplicity adjustment is not necessary by using the closed testing (CT) principle. In fact, using the same argument, no multiplicity adjustment is necessary in simultaneous testing of any number of nested null hypotheses. However, simultaneous testing of many nested null hypotheses is problematic in a confirmatory trial because such simultaneous testing is similar to post-hoc specification of the null hypothesis. Thus, simultaneous testing for noninferiority and superiority may be viewed as an initial step towards exploratory analysis and may be best used cautiously in confirmatory evaluation.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
1054-3406
pubmed:author
pubmed:issnType
Print
pubmed:volume
13
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
629-39; discussion 641-62
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2003
pubmed:articleTitle
Issues of simultaneous tests for noninferiority and superiority.
pubmed:affiliation
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852-1448, USA. ng@cber.fda.gov
pubmed:publicationType
Journal Article, Comment