Despite substantial agreement with points made by Andrew C. Leon, PhD, in his article, I am not in complete agreement in a few areas. The definition of noninferiority proposed by Leon allows drugs somewhat less effective than placebo to be characterized as noninferior to placebo, and 2 active drugs may each be simultaneously noninferior to the other. Moreover, including a placebo arm in comparing 2 active drugs is of no use in deciding whether the study is well designed or not, since a significant difference between one of the active arms and the placebo may be due to chance or to a bias in the design. An alternative view of the situation is presented.
%0 Journal Article
%1 Kraemer2011
%A Kraemer, Helena Chmura
%D 2011
%J The Journal of clinical psychiatry
%K ComparativeEffectivenessResearch ComparativeEffectivenessResearch:standards Humans Psychiatry Psychiatry:methods RandomizedControlledTrialsasTopic:standards ResearchDesign ResearchDesign:standards RCT
%N 10
%P 1350-2
%R 10.4088/JCP.10com06607whi
%T Another point of view: superiority, noninferiority, and the role of active comparators.
%U http://www.ncbi.nlm.nih.gov/pubmed/22075101
%V 72
%X Despite substantial agreement with points made by Andrew C. Leon, PhD, in his article, I am not in complete agreement in a few areas. The definition of noninferiority proposed by Leon allows drugs somewhat less effective than placebo to be characterized as noninferior to placebo, and 2 active drugs may each be simultaneously noninferior to the other. Moreover, including a placebo arm in comparing 2 active drugs is of no use in deciding whether the study is well designed or not, since a significant difference between one of the active arms and the placebo may be due to chance or to a bias in the design. An alternative view of the situation is presented.
%@ 1555-2101; 0160-6689
@article{Kraemer2011,
abstract = {Despite substantial agreement with points made by Andrew C. Leon, PhD, in his article, I am not in complete agreement in a few areas. The definition of noninferiority proposed by Leon allows drugs somewhat less effective than placebo to be characterized as noninferior to placebo, and 2 active drugs may each be simultaneously noninferior to the other. Moreover, including a placebo arm in comparing 2 active drugs is of no use in deciding whether the study is well designed or not, since a significant difference between one of the active arms and the placebo may be due to chance or to a bias in the design. An alternative view of the situation is presented.},
added-at = {2023-02-03T11:44:35.000+0100},
author = {Kraemer, Helena Chmura},
biburl = {https://www.bibsonomy.org/bibtex/29bca600d01bf8d85b2b2120bb941aec1/jepcastel},
doi = {10.4088/JCP.10com06607whi},
interhash = {cb2d0277052d72a16381fa3d6828833e},
intrahash = {9bca600d01bf8d85b2b2120bb941aec1},
isbn = {1555-2101; 0160-6689},
issn = {1555-2101},
journal = {The Journal of clinical psychiatry},
keywords = {ComparativeEffectivenessResearch ComparativeEffectivenessResearch:standards Humans Psychiatry Psychiatry:methods RandomizedControlledTrialsasTopic:standards ResearchDesign ResearchDesign:standards RCT},
month = {10},
note = {7070<m:linebreak></m:linebreak>LR: 20120815; CI: (c) Copyright 2011; JID: 7801243; CON: J Clin Psychiatry. 2011 Oct;72(10):1344-9. PMID: 21367350; 2010/09/30 [received]; 2010/09/30 [accepted]; ppublish;},
number = 10,
pages = {1350-2},
pmid = {22075101},
timestamp = {2023-05-04T08:59:38.000+0200},
title = {Another point of view: superiority, noninferiority, and the role of active comparators.},
url = {http://www.ncbi.nlm.nih.gov/pubmed/22075101},
volume = 72,
year = 2011
}