论文标题

统计问题和建议在COVID-19大流行期间进行的临床试验

Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

论文作者

Meyer, R. Daniel, Ratitch, Bohdana, Wolbers, Marcel, Marchenko, Olga, Quan, Hui, Li, Daniel, Fletcher, Chrissie, Li, Xin, Wright, David, Shentu, Yue, Englert, Stefan, Shen, Wei, Dey, Jyotirmoy, Liu, Thomas, Zhou, Ming, Bohidar, Norman, Zhao, Peng-Liang, Hale, Michael

论文摘要

COVID-19大流行对计划和正在进行的临床试验产生了重大影响。它对试验数据的影响会引起多个潜在的统计问题。影响的规模是前所未有的,但是当单独观察时,许多问题是明确的且可行的。提出了许多策略和建议,以评估和解决与估计数,丢失数据,有效性和统计分析方法的修改有关的问题,需要其他分析,实现目标的能力和整体试验解释性。

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.

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