منابع مشابه
Noninferiority 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.
متن کاملEquivalence and non inferiority trials
Many effective drugs, biologics and devices exist. Because of this, it is often considered unethical to undertake placebo controlled clinical trials to evaluate new treatments. Rather, randomized active control noninferiority trials have become the norm. These trials, however, are accompanied by serious issues including selecting an active comparator, identifying previously run active comparato...
متن کاملAssessing treatment efficacy in noninferiority trials.
Often one of the primary objectives of an active-controlled noninferiority trial without a placebo arm is to assert that an experimental treatment would have been more effective than a putative placebo had the placebo been included in the trial. This may be an important consideration for regulatory applications. To achieve this objective, such a noninferiority analysis entails cross-trial stati...
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ژورنال
عنوان ژورنال: ANZ Journal of Surgery
سال: 2020
ISSN: 1445-1433,1445-2197
DOI: 10.1111/ans.15592