Noninferiority trials: clinical understandings and misunderstandings
نویسندگان
چکیده
منابع مشابه
Repairing conversational misunderstandings and non-understandings
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متن کاملNoninferiority trials
Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty in specifying...
متن کاملUnderstanding noninferiority trials
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical...
متن کاملThe pros and cons of noninferiority trials.
Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group, types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider.
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ژورنال
عنوان ژورنال: Clinical Investigation
سال: 2013
ISSN: 2041-6792,2041-6806
DOI: 10.4155/cli.12.157