The Medical Letter on Drugs and Therapeutics
January 10, 2011
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In Brief: Non-Inferiority Trials
January 10, 2011 (Issue: 1355)Several Medical Letter readers have asked about the meaning of non-inferiority trials. A non-inferiority trial is a comparison with an active control to determine whether the difference in response between the new drug and the active control is small...more
1. Guidance for industry non-inferiority clinical trials. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf. Accessed December 17, 2010.
2. ICH Harmonised Tripartite Guideline. Choice of control group and related issues in clinical trials E10. http://private.ich.org/LOB/media/MEDIA486.pdf. Accessed December 17, 2010.
3. R Temple and SS Ellenberg. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 2000; 133:464.
4. FDA issues first draft guidance on noninferiority trial. http://www.fdanews.com/newsletter/article?articleId=124913&issueId=13475. Accessed December 17, 2010.
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