Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic. (1st October 2020)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Statistics in biopharmaceutical research. Volume 12:Number 4(2020)
• Page Start: 399
• Page End: 411
• Publication Date: 2020-10-01
• Subjects: Clinical trials -- COVID-19 -- Estimands -- Missing data -- Pandemic -- Statistical strategy -- Supportive analyses; Pharmacy -- Statistical methods -- Periodicals; Pharmaceutical biotechnology -- Statistical methods -- Periodicals; Biopharmaceutics -- Periodicals; Biometry -- Periodicals; Pharmacy -- Statistical methods; Periodicals; 615.190727
• DOI: 10.1080/19466315.2020.1779122
• Languages: English
• ISSNs: 1946-6315

Abstract

Abstract : 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.