Proceedings of a symposiumDesign and interpretation of equivalence trials
References (12)
The case for confidence intervals in controlled clinical trials
Control Clin Trials
(1994)The glitter of the t table
Lancet
(1993)- et al.
Results of a randomized trial comparing idarubicin and cytosine arabinoside with dounorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia
Blood
(1991) A comparison of reteplase with alteplase for acute myocardial infarction
N Engl J Med
(1997)Thrombolytic therapy and equivalence trials
J Am Coll Cardiol
(1998)- et al.
Differences between clinical and statistical significance
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2015, Journal of Thoracic and Cardiovascular SurgeryCitation Excerpt :For those predictor variables that did not fulfill the proportionality assumptions, stratified analyses were done. Comparisons with LITA: With the aim of investigating noninferiority and equivalence of the SV techniques with LITA, the approach recommended by Fleming19 and Christensen20 was used. Results are shown as confidence intervals (CI) for the differences in patency rates between the investigated techniques (LITA–SV).
The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment
2015, Journal of Clinical EpidemiologyCitation Excerpt :Noninferiority randomized trials are an increasingly popular study design, especially in the field of oncology, infectious diseases, or cardiovascular diseases [1,2]. The main purpose of such trials is to demonstrate that a new treatment is not substantially less effective than an existing treatment, while providing an additional advantage (in terms of convenience, burden of treatment, side effects, cost, and so forth.) [3]. A key challenge for such studies is to define what “not substantially less effective” means.
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2011, Annals of Emergency MedicineCitation Excerpt :In an equivalence trial, the null hypothesis is that the experimental treatment is either better or worse than the active comparator, with a treatment effect that falls outside the range of −Δ margin to +Δ margin. If the study produces a result that falls between the region −Δ to Δ, we reject the null hypothesis that 2 drugs differ, thereby implying that they may be the same.14-16,18-20 In a noninferiority trial, the null hypothesis is that the experimental treatment is worse than the alternative treatment by −Δ.