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COVID-19:改变随机试验的催化剂。

COVID-19: A Catalyst for Transforming Randomized Trials.

机构信息

Department of Anesthesiology, Columbia University Irving Medical Center, New York, NY.

Department of Medicine, Stanford Prevention Research Center.

出版信息

J Neurosurg Anesthesiol. 2022 Jan 1;34(1):107-112. doi: 10.1097/ANA.0000000000000804.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic incited a global clinical trial research agenda of unprecedented speed and high volume. This expedited research activity in a time of crisis produced both successes and failures that offer valuable learning opportunities for the scientific community to consider. Successes include the implementation of large adaptive and pragmatic trials as well as burgeoning efforts toward rapid data synthesis and open science principles. Conversely, notable failures include: (1) inadequate study design and execution; (2) data reversal, fraud, and retraction; and (3) research duplication and waste. Other challenges that became highlighted were the need to find unbiased designs for investigating complex, nonpharmaceutical interventions and the use of routinely collected data for outcomes assessment. This article discusses these issues juxtaposing the COVID-19 trials experience against trials in anesthesiology and other fields. These lessons may serve as a positive catalyst for transforming future clinical trial research.

摘要

2019 年冠状病毒病(COVID-19)大流行引发了一项全球临床试验研究议程,其速度和规模前所未有。在这场危机中,加速进行的研究活动既有成功也有失败,为科学界提供了宝贵的学习机会。成功的例子包括实施大型适应性和实用临床试验,以及迅速开展数据综合和开放科学原则的努力。相反,值得注意的失败包括:(1)研究设计和执行不充分;(2)数据反转、欺诈和撤回;(3)研究重复和浪费。其他突显的挑战包括需要为调查复杂的非药物干预措施找到无偏设计,以及利用常规收集的数据进行结果评估。本文将 COVID-19 试验的经验与麻醉学和其他领域的试验进行对比,讨论这些问题。这些经验教训可能成为推动未来临床试验研究变革的积极催化剂。

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