Some practical considerations in three-arm non-inferiority trial design
Author:
Affiliation:
1. Global Biometric Sciences; Bristol-Myers Squibb; Princeton NJ USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Reference24 articles.
1. US Food and Drug Administration (FDA) Guidance for industry non-inferiority clinical. Rockville 2010
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3. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics;D'Agostino;Statistics in Medicine,2003
4. Challenges and regulatory experiences with non-inferiority trial design without placebo arm;Hung;Biometrical Journal,2009
5. Testing non-inferiority of a new treatment in three-arm clinical trials with binary endpoints;Tang;BMC Medical Research Methodology,2014
Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Sample Size Calculation for “Gold-Standard” Noninferiority Trials With Fixed Margins and Negative Binomial Endpoints;Statistics in Biopharmaceutical Research;2020-06-08
2. Sequential parallel comparison design for “gold standard” noninferiority trials with a prespecified margin;Biometrical Journal;2019-08-28
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