198
Views
6
CrossRef citations to date
0
Altmetric
Reviews

Systematic evaluation of non-inferiority and equivalence randomized trials of anti-infective drugs

, , , , , , & show all
Pages 1377-1389 | Published online: 10 Jan 2014

References

  • Christensen E. Methodology of superiority vs, equivalence trials and non-inferiority trials. J. Hepatol. 46(5), 947–954 (2007).
  • Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 308(24), 2594–2604 (2012).
  • Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N. Engl. J. Med. 331(6), 394–398 (1994).
  • Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatment exists? Ann. Intern. Med. 133(6), 474–475 (2000).
  • Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients’ interests. Lancet 370(9602), 1875–1877 (2007).
  • Chuang-Stein C, Beltangady M, Dunne M, Morrison B. The ethics of non-inferiority trials. Lancet 371(9616), 895–896, author reply 896–897 (2008).
  • Menten J, Boelaert M. The ethics of non-inferiority trials. Lancet 371(9616), 896, author reply 896–897 (2008).
  • Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. The ethics of non-inferiority trials. Lancet 371(9616), 895, author reply 896–897 (2008).
  • Gandjour A. The ethics of non-inferiority trials. Lancet 371(9616), 895 (2008).
  • Soliman EZ. The ethics of non-inferiority trials. Lancet 371(9616), 895, author reply 896–897 (2008).
  • Piaggio G, Elbourne DR, Altman DG et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 295(10), 1152–1160 (2006).
  • Nduba VN, Mwachari CW, Magaret AS et al. Placebo found equivalent to amoxicillin for treatment of acute bronchitis in Nairobi, Kenya: a triple blind, randomised, equivalence trial. Thorax 63(11), 999–1005 (2008).
  • Hazir T, Nisar YB, Abbasi S et al. Comparison of oral amoxicillin with placebo for the treatment of world health organization-defined nonsevere pneumonia in children aged 2–59 months: a multicenter, double-blind, randomized, placebo-controlled trial in Pakistan. Clin. Infect. Dis. 52(3), 293–300 (2011).
  • Awasthi S, Agarwal G, Kabra SK et al. Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze: a multicentric randomised controlled trial. PLoS ONE 3(4), e1991 (2008).
  • Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann. Emerg. Med. 55(5), 401–407 (2010).
  • Autret-Leca E, Giraudeau B, Ployet MJ, Jonville-Bera AP. Amoxicillin/clavulanic acid is ineffective at preventing otitis media in children with presumed viral upper respiratory infection: a randomized, double-blind equivalence, placebo-controlled trial. Br. J. Clin. Pharmacol. 54(6), 652–656 (2002).
  • Shapiro RL, Thior I, Gilbert PB et al. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana. AIDS 20(9), 1281–1288 (2006).
  • Saag M, Goodrich J, Fatkenheuer G et al. A double-blind, placebo-controlled trial of maraviroc in treatment-experienced patients infected with non-R5 HIV-1. J. Infect. Dis. 199(11), 1638–1647 (2009).
  • Firnhaber C, Azzoni L, Foulkes AS et al. Randomized trial of time-limited interruptions of protease inhibitor-based antiretroviral therapy (ART) vs. continuous therapy for HIV-1 infection. PLoS ONE 6(6), e21450 (2011).
  • Sterling TR, Villarino ME, Borisov AS et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N. Engl. J. Med. 365(23), 2155–2166 (2011).
  • Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 295(10), 1147–1151 (2006).
  • D’Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics. Stat. Med. 22(2), 169–186 (2003).
  • Fleming TR. Current issues in non-inferiority trials. Stat. Med. 27(3), 317–332 (2008).
  • Everson-Stewart S, Emerson SS. Bio-creep in non-inferiority clinical trials. Stat. Med. 29(27), 2769–2780 (2010).
  • Committee for Proprietary Medicinal Products. Points to consider on switching between superiority and non-inferiority. Br. J. Clin. Pharmacol. 52(3), 223–228 (2001).
  • Brittain E, Lin D. A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials. Stat Med. 24(1), 1–10 (2005).
  • Abraha I, Montedori A. Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ 340, c2697 (2010).
  • Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 309(8), 814–822 (2013).
  • Porcino AJ. The Greater Value of the CONSORT Statement Guidelines: Guideposts for Designing and Reporting all TMB Research. Int. J. Ther. Massage Bodywork 5(4), 1–2 (2012).
  • Powers JH. Noninferiority and equivalence trials: deciphering ‘similarity’ of medical interventions. Stat. Med. 27(3), 343–352 (2008).
  • Eyawo O, Lee CW, Rachlis B, Mills EJ. Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature. Trials 9, 69 (2008).
  • Lavender T, Furber C, Campbell M, et al. Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial. BMC Pediatr. 12, 59 (2012).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.