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心脏病学中的适应性试验:一些考量与实例

Adaptive Trials in Cardiology: Some Considerations and Examples.

作者信息

Mandrola John, Althouse Andrew D, Foy Andrew, Bhatt Deepak L

机构信息

Baptist Health Louisville, Louisville, Kentucky, USA.

Center for Clinical Trials and Data Coordination, Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

出版信息

Can J Cardiol. 2021 Sep;37(9):1428-1437. doi: 10.1016/j.cjca.2021.06.023. Epub 2021 Jul 10.

Abstract

Adaptive trials hold great promise to enhance the evidence base supporting medical interventions. In this review, we will describe the basic principles of an adaptive trial and the different types of adaptive trials, show examples of adaptive trials, and conclude with the advantages and challenges of different types of adaptive trials. While regulatory bodies have expressed a desire to see more adaptive trials, resistance in the community remains. We hope that this review helps to build greater acceptance of the concept of adaptive trial design.

摘要

适应性试验有望极大地增强支持医学干预措施的证据基础。在本综述中,我们将描述适应性试验的基本原则和不同类型的适应性试验,展示适应性试验的实例,并以不同类型适应性试验的优势和挑战作为总结。虽然监管机构已表示希望看到更多的适应性试验,但业内仍存在阻力。我们希望本综述有助于提高对适应性试验设计概念的接受度。

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