The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials.
The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials.
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DOI：
10.1038/s43856-023-00281-1
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发表时间：
2023-04-17
期刊：
影响因子：
--
通讯作者：
Mills, Edward
中科院分区：
文献类型：
--
作者：
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
临床试验终点必须仔细和有意地选择，以便试验结果可用于制定政策和决策。潜在终点的相对重要性通常取决于利益相关者，患者对政策制定者和监管机构的偏好不同。COVID-19临床试验的建立存在问题，因为可以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，这使得及时比较和评价干预措施变得困难。在这里，我们讨论了COVID-19形势的演变，以及这对选择一致和可测量的临床试验终点的影响。使用适当的终点对于研究人员提供最可靠，有效和可解释的结果至关重要。Thorlund等人讨论了为门诊COVID-19临床试验选择适当终点时的考虑因素。2019冠状病毒病大流行期间患者预后的改善需要对评估的预后进行变更。
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. Thorlund et al. discuss considerations when selecting appropriate endpoints for outpatient COVID-19 clinical trials. Improvements in patient outcomes during the COVID-19 pandemic have necessitated changes to the outcomes being assessed.
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DOI：
10.1016/s2214-109x(21)00448-4
发表时间：
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期刊：
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发表时间：
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期刊：
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