Literature DB >> 32900680

Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review.

Anthony D Bai1, Adam S Komorowski2, Carson K L Lo3, Pranav Tandon4, Xena X Li3,2, Vaibhav Mokashi3, Anna Cvetkovic3, Aidan Findlater3, Laurel Liang5, Mark Loeb3, Dominik Mertz3.   

Abstract

Novel antibiotics approved by noninferiority trials may become less effective over time in two scenarios: (i) the treatment effect in studies of novel antibiotics may be consistently worse than studies of older antibiotics; (ii) when a decreasingly effective control arm is used in a series of noninferiority trials. Our systematic review of 175 noninferiority antibiotic trials found these scenarios to be rare.
Copyright © 2020 American Society for Microbiology.

Keywords:  anti-infective agents; antibacterial agents; noninferiority trials; systematic review

Year:  2020        PMID： 32900680      PMCID： PMC7577162          DOI： 10.1128/AAC.01597-20

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN： 0066-4804            Impact factor:   5.191


  7 in total

1.  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

2.  Bio-creep in non-inferiority clinical trials.

Authors:  Siobhan Everson-Stewart; Scott S Emerson
Journal:  Stat Med       Date:  2010-11-30       Impact factor: 2.373

3.  A simulation study evaluating bio-creep risk in serial non-inferiority clinical trials for preservation of effect.

Authors:  K Odem-Davis; T R Fleming
Journal:  Stat Biopharm Res       Date:  2015-01-01       Impact factor: 1.452

4.  The Cochrane Collaboration's tool for assessing risk of bias in randomised trials.

Authors:  Julian P T Higgins; Douglas G Altman; Peter C Gøtzsche; Peter Jüni; David Moher; Andrew D Oxman; Jelena Savovic; Kenneth F Schulz; Laura Weeks; Jonathan A C Sterne
Journal:  BMJ       Date:  2011-10-18

5.  Do non-inferiority trials of reduced intensity therapies show reduced effects? A descriptive analysis.

Authors:  Scott K Aberegg; Andrew M Hersh; Matthew H Samore
Journal:  BMJ Open       Date:  2018-03-02       Impact factor: 2.692

6.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.

Authors:  David Moher; Alessandro Liberati; Jennifer Tetzlaff; Douglas G Altman
Journal:  PLoS Med       Date:  2009-07-21       Impact factor: 11.069

Review 7.  Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.

Authors:  John H Rex; George H Talbot; Mark J Goldberger; Barry I Eisenstein; Roger M Echols; John F Tomayko; Michael N Dudley; Aaron Dane
Journal:  Clin Infect Dis       Date:  2017-07-01       Impact factor: 9.079
  7 in total
  1 in total

1.  Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?

Authors:  Adam S Komorowski; Anthony D Bai; Anna Cvetkovic; Omar Mourad; Carson K L Lo; Xena X Li; Vaibhav Mokashi; Aidan Findlater; D Brody Duncan; Charlotte Fuller; Daniela L Leto; Deborah Yamamura; Dominik Mertz
Journal:  Antimicrob Agents Chemother       Date:  2021-10-18       Impact factor: 5.938
  1 in total

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