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

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

doi:10.6084/m9.figshare.12445475.v2

usbr_a_1779122_sm0821.pdf (292.77 kB)

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

Version 2 2020-08-21, 18:15

Version 1 2020-06-08, 13:40

journal contribution

posted on 2020-08-21, 18:15 authored by R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers, Olga Marchenko, Hui Quan, Daniel Li, Christine Fletcher, Xin Li, David Wright, Yue Shentu, Stefan Englert, Wei Shen, Jyotirmoy Dey, Thomas Liu, Ming Zhou, Norman Bohidar, Peng-Liang Zhao, Michael Hale

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.