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在门诊COVID-19临床试验中合理选择临床终点的重要性。

The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials.

作者信息

Thorlund Kristian, Smith Davey, Linsell Christopher, White Nicholas, Butler Christopher, Boulware David, Currier Judith, Harari Ofir, Lhomme Edouard, Strub-Wourgaft Nathalie, Adam Stacey, Mills Edward

机构信息

McMaster University, Hamilton, Canada.

School of Health Sciences, University of California San Diego, San Diego, CA, USA.

出版信息

Commun Med (Lond). 2023 Apr 17;3(1):53. doi: 10.1038/s43856-023-00281-1.

Abstract

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible.

摘要

必须谨慎且有意地选择临床试验终点,以便试验结果能够用于为政策制定和决策提供依据。潜在终点的相对重要性通常取决于利益相关者,患者与政策制定者和监管机构的偏好不同。新冠病毒疾病(COVID-19)临床试验的设置存在问题,因为能够合理测量的终点并不总是与指南小组通常要求的疗效终点相匹配。因此,使用了不同的终点,这使得对干预措施进行及时比较和评估变得困难。在此,我们讨论COVID-19形势的演变及其对选择一致且可测量的临床试验终点的影响。使用恰当的终点对于研究人员提供尽可能最可靠、有效且可解释的结果至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f373/10110582/6f25bc6bf49a/43856_2023_281_Fig1_HTML.jpg

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