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行业资助的心脏设备试验中的数据呈现。

Data presentation in industry-sponsored cardiac device trials.

作者信息

Chandrasekar Baskaran

机构信息

Department of Cardiology, Chest Diseases Hospital, PO Box 4082, Safat, 13041, Kuwait.

出版信息

Indian Heart J. 2025 Jan-Feb;77(1):48-50. doi: 10.1016/j.ihj.2025.01.004. Epub 2025 Jan 24.

DOI:10.1016/j.ihj.2025.01.004
PMID:39864518
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11977135/
Abstract

Industry's influence on clinical trials is well known and extends to various aspects beyond funding, including industry-affiliated authors and industry-affiliated analysts. An area of potential concern is presentation of analyzed data that does not appear favorable to the desired study outcome. Such important data are at times not accorded prominence in discussion. The present article analyses such concerns in data presentation in the landmark trials of two cardiac devices the use of which has increased markedly in recent years (DanGer Shock trial and COAPT trial). It is seen that important data that did not appear favorable to the intended study outcome were relegated mostly to Supplement Section, where they are likely to receive less attention, with little discussion allocated in the text.

摘要

业界对临床试验的影响是众所周知的,并且其影响范围超出了资金领域,涉及包括业界附属作者和业界附属分析师在内的各个方面。一个潜在令人担忧的领域是呈现出的分析数据似乎不利于预期的研究结果。这类重要数据有时在讨论中未得到突出体现。本文分析了近年来使用量显著增加的两种心脏设备的里程碑式试验(DanGer Shock试验和COAPT试验)中数据呈现方面的此类问题。可以看到,那些看似不利于预期研究结果的重要数据大多被归入补充部分,在那里它们可能较少受到关注,正文中也几乎没有对其进行讨论。

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本文引用的文献

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Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022.2019-2022 年,引用最多的临床试验中的行业参与和透明度。
JAMA Netw Open. 2023 Nov 1;6(11):e2343425. doi: 10.1001/jamanetworkopen.2023.43425.
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Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation.经导管修复二尖瓣反流后的 5 年随访。
N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
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The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System.胸外科医师协会Intermacs 2022年度报告:聚焦2018年心脏移植分配系统
Ann Thorac Surg. 2023 Feb;115(2):311-327. doi: 10.1016/j.athoracsur.2022.11.023. Epub 2022 Dec 1.
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JAMA. 2021 Aug 3;326(5):433-434. doi: 10.1001/jama.2021.2825.
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The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support.美国经皮冠状动脉介入治疗中机械循环支持患者中 Impella 使用的演变情况。
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