Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
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DOI：
10.1080/19466315.2020.1779122
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发表时间：
2020-07-03
影响因子：
1.8
通讯作者：
Hale, Michael
中科院分区：
文献类型：
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作者：
Meyer, R. Daniel;Ratitch, Bohdana;Hale, Michael
新冠肺炎大流行已经并将继续对计划中的和正在进行的临床试验产生重大影响。它对试验数据的影响产生了多个潜在的统计问题。影响的规模是史无前例的，但当单独来看，许多问题都定义得很清楚，解决起来也是可行的。提出了一些战略和建议，以评估和解决与以下问题有关的问题：标准、数据缺失、统计分析方法的有效性和修改、额外分析的必要性、实现目标的能力和总体审判的可解释性。
The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. A number of strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability.