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非劣效性试验设计和解读中的挑战：来自最近支架试验的见解。

Challenges in the Design and Interpretation of Noninferiority Trials: Insights From Recent Stent Trials.

机构信息

Department of Interventional Cardiology, Hospital Clínico San Carlos-Universidad Complutense Madrid, Madrid, Spain.

Department of Interventional Cardiology, Hospital Clínico San Carlos-Universidad Complutense Madrid, Madrid, Spain.

出版信息

J Am Coll Cardiol. 2017 Aug 15;70(7):894-903. doi: 10.1016/j.jacc.2017.06.039.

DOI:10.1016/j.jacc.2017.06.039
PMID:28797360
Abstract

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.

摘要

非劣效性设计在当前的临床研究中得到了广泛应用，但它复杂的特点可能会妨碍对这些试验的正确解读。因此，理解非劣效性设计的基本原则是必不可少的。作者讨论了关于非劣效性试验设计和解读的基本概念，然后通过分析一组当代冠状动脉支架试验来探讨一些常见的方法学批评。最后，作者给出了一个全面的视角，以提高未来试验的设计和实施。

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