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临床试验中复合终点的使用趋势:急性心力衰竭试验与COVID-19试验的比较。

Trends in use of composite endpoints in clinical trials: A comparison between acute heart failure trials and COVID-19 trials.

作者信息

Shi Lan, Lindsell Christopher John, Liu Dandan

机构信息

Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.

Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA.

出版信息

J Clin Transl Sci. 2024 Mar 8;8(1):e55. doi: 10.1017/cts.2024.492. eCollection 2024.

DOI:10.1017/cts.2024.492
PMID:38617062
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11010049/
Abstract

Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly. We conducted a literature review to investigate the use of composite endpoints in acute heart failure and COVID-19 clinical trials. The results showed more frequent use of patient-oriented outcomes and ordinal composite endpoints in COVID-19 trials, which might be driven by global consensus on a set of common outcome measures.

摘要

复合终点可以编码多条信息,并且在临床试验中越来越多地被采用。几十年前,在心血管试验中就开始倡导使用复合终点,这导致纳入了以患者为导向的结局,并考虑了分层排序系统。在冠状病毒病(COVID-19)试验中,复合终点的使用也有类似的发展。我们进行了一项文献综述,以调查复合终点在急性心力衰竭和COVID-19临床试验中的使用情况。结果显示,在COVID-19试验中,以患者为导向的结局和有序复合终点的使用更为频繁,这可能是由一套共同结局指标的全球共识所推动的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a07d/11010049/17c1543642f8/S2059866124004928_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a07d/11010049/5ae17f79b2df/S2059866124004928_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a07d/11010049/17c1543642f8/S2059866124004928_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a07d/11010049/5ae17f79b2df/S2059866124004928_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a07d/11010049/17c1543642f8/S2059866124004928_fig2.jpg

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本文引用的文献

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The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials.在门诊COVID-19临床试验中合理选择临床终点的重要性。
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Endpoints in Heart Failure Drug Development.心力衰竭药物研发中的终点指标
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10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.ST 段抬高型心肌梗死患者采用依维莫司洗脱支架与裸金属支架 10 年随访结果。
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