Literature DB >> 22908144

The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants.

Grace Wangge1, Kit C B Roes, Anthonius de Boer, Arno W Hoes, Mirjam J Knol.   

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Year:  2012        PMID： 22908144      PMCID： PMC3576440          DOI： 10.1503/cmaj.120142

Source DB:  PubMed          Journal:  CMAJ        ISSN： 0820-3946            Impact factor:   8.262


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  19 in total

1.  Design and interpretation of equivalence trials.

Authors:  T R Fleming
Journal:  Am Heart J       Date:  2000-04       Impact factor: 4.749

2.  Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics.

Authors:  Ralph B D'Agostino; Joseph M Massaro; Lisa M Sullivan
Journal:  Stat Med       Date:  2003-01-30       Impact factor: 2.373

Review 3.  Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials.

Authors:  Sanjay Kaul; George A Diamond
Journal:  Prog Cardiovasc Dis       Date:  2007 Jan-Feb       Impact factor: 8.194

Review 4.  Choice of delta: requirements and reality--results of a systematic review.

Authors:  S Lange; G Freitag
Journal:  Biom J       Date:  2005-02       Impact factor: 2.207

Review 5.  A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials.

Authors:  H M James Hung; Sue-Jane Wang; Robert O'Neill
Journal:  Biom J       Date:  2005-02       Impact factor: 2.207

6.  Apixaban versus enoxaparin for thromboprophylaxis after hip replacement.

Authors:  Michael Rud Lassen; Alexander Gallus; Gary E Raskob; Graham Pineo; Dalei Chen; Luz Margarita Ramirez
Journal:  N Engl J Med       Date:  2010-12-23       Impact factor: 91.245

Review 7.  Room for improvement in conducting and reporting non-inferiority randomized controlled trials on drugs: a systematic review.

Authors:  Grace Wangge; Olaf H Klungel; Kit C B Roes; Anthonius de Boer; Arno W Hoes; Mirjam J Knol
Journal:  PLoS One       Date:  2010-10-27       Impact factor: 3.240

8.  The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study.

Authors:  B I Eriksson; G Agnelli; A T Cohen; O E Dahl; M R Lassen; P Mouret; N Rosencher; P Kälebo; S Panfilov; C Eskilson; M Andersson; A Freij
Journal:  J Thromb Haemost       Date:  2003-12       Impact factor: 5.824

9.  Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.

Authors:  Bengt I Eriksson; Ola E Dahl; Nadia Rosencher; Andreas A Kurth; C Niek van Dijk; Simon P Frostick; Martin H Prins; Rohan Hettiarachchi; Stefan Hantel; Janet Schnee; Harry R Büller
Journal:  Lancet       Date:  2007-09-15       Impact factor: 79.321

10.  Comparison of ximelagatran, an oral direct thrombin inhibitor, with enoxaparin for the prevention of venous thromboembolism following total hip replacement. A randomized, double-blind study.

Authors:  C W Colwell; S D Berkowitz; B L Davidson; P A Lotke; J S Ginsberg; J R Lieberman; J Neubauer; J L McElhattan; G R Peters; C W Francis
Journal:  J Thromb Haemost       Date:  2003-10       Impact factor: 5.824
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  9 in total

1.  Non-inferiority Testing for Risk Ratio, Odds Ratio and Number Needed to Treat in Three-arm Trial.

Authors:  Shrabanti Chowdhury; Ram C Tiwari; Samiran Ghosh
Journal:  Comput Stat Data Anal       Date:  2018-09-15       Impact factor: 1.681

2.  Bayesian Approach for Assessing Non-inferiority in Three-arm Trials for Risk Ratio and Odds Ratio.

Authors:  Shrabanti Chowdhury; Ram C Tiwari; Samiran Ghosh
Journal:  Stat Biopharm Res       Date:  2019-04-22       Impact factor: 1.452

3.  Design of non-inferiority randomized trials using the difference in restricted mean survival times.

Authors:  Isabelle R Weir; Ludovic Trinquart
Journal:  Clin Trials       Date:  2018-08-03       Impact factor: 2.486

4.  Defining the noninferiority margin and analysing noninferiority: An overview.

Authors:  Turki A Althunian; Anthonius de Boer; Rolf H H Groenwold; Olaf H Klungel
Journal:  Br J Clin Pharmacol       Date:  2017-04-06       Impact factor: 4.335

5.  A Local Sensitivity Analysis of the Trial of Continuous or Interrupted Chest Compressions during Cardiopulmonary Resuscitation: Is a Local Protocol Change Required?

Authors:  Brian Grunau; Joel Singer; Terry Lee; Frank X Scheuermeyer; Ron Straight; Robert Schlamp; Robert Wand; William F Dick; Helen Connolly; Sarah Pennington; Jim Christenson
Journal:  Cureus       Date:  2018-09-29

6.  A note on the determination of non-inferiority margins with application in oncology clinical trials.

Authors:  Binbing Yu; Harry Yang; Antony Sabin
Journal:  Contemp Clin Trials Commun       Date:  2019-09-23

Review 7.  A clinician's guide to the assessment and interpretation of noninferiority trials for novel therapies.

Authors:  Simon J W Oczkowski
Journal:  Open Med       Date:  2014-05-06

8.  Choice of non-inferiority (NI) margins does not protect against degradation of treatment effects on an average--an observational study of registered and published NI trials.

Authors:  Beryl Primrose Gladstone; Werner Vach
Journal:  PLoS One       Date:  2014-07-31       Impact factor: 3.240

9.  The Impact of the Underlying Risk in Control Group and Effect Measures in Non-Inferiority Trials With Time-to-Event Data: A Simulation Study.

Authors:  Xuanqian Xie; Chenglin Ye; Nicholas Mitsakakis
Journal:  J Clin Med Res       Date:  2018-03-16
  9 in total

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