Modelling of the outcome of non-inferiority trials by integration of historical data-Reference-Cited by-同舟云学术

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Modelling of the outcome of non-inferiority trials by integration of historical data

Published:2011-08-21 Issue:5 Volume:38 Page:595-612
ISSN:1567-567X
Container-title:Journal of Pharmacokinetics and Pharmacodynamics
language:en
Short-container-title:J Pharmacokinet Pharmacodyn

Author:

Russu Alberto,van Zwet Erik,De Nicolao Giuseppe,Della Pasqua Oscar

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s10928-011-9210-8

Reference45 articles.

1. Kaul S, Diamond GA (2006) Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med 145:62–69

2. Carroll KJ (2006) Active-controlled, non-inferiority trials in oncology: arbitrary limits, infeasible sample sizes and uninformative data analysis. Is there another way? Pharm Stat 5:283–293

3. Garattini S, Bertelé V (2007) Non-inferiority trials are unethical because they disregard patients’ interests. Lancet 370:1875–1877

4. Simon R (2000) Are placebo-controlled clinical trials ethical or needed when alternative treatment exists? Ann Intern Med 133:474–475

5. Food and Drug Administration (2010). Guidance for Industry, Non-Inferiority Clinical Trials. March 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf

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1. Article Alerts: items from 2011, Part II;Research Synthesis Methods;2015-06-20

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