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Review outlines core principles and methodological pitfalls in contemporary noninferiority coronary stent trials.
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Provides a methodological overview of the design and interpretation of noninferiority trials, highlighting common criticisms through the lens of contemporary coronary stent trials.
The noninferiority design is used extensively in current clinical research, but its complex features may hamper the appropriate interpretation of such trials. Thus, understanding the pillars of noninferiority design is indispensable. The authors discuss fundamental concepts regarding the design and interpretation of noninferiority trials and then explore some common methodological criticism by analyzing a sample of contemporary coronary stent trials. Finally, the authors give an overall perspective to enhance the design and conduct of future trials.
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Macaya et al. (2017) conducted a review in Coronary stent trials. This review discusses fundamental concepts regarding the design and interpretation of noninferiority trials and explores common methodological criticisms using contemporary coronary stent trials.
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