Abstract–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.

中文翻译：

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COVID-19大流行期间进行的临床试验的统计问题和建议

摘要– COVID-19大流行已对并将继续对计划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，但是从各个角度来看，许多问题是明确定义的，可以解决。提出了许多策略和建议，以评估和解决与估计数，数据缺失，统计分析方法的有效性和修改，需要进行额外分析，达到目标的能力和整体试验的可解释性有关的问题。