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

Autor:	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
Rok vydání:	2020
Předmět:	Quantitative Biology - Other Quantitative Biology
Druh dokumentu:	Working Paper
Popis:	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. Comment: Accepted for publication in Statistics in Biopharmaceutical Research. 40 pages
Databáze:	arXiv
Externí odkaz:	http://arxiv.org/abs/2005.10248 Zobrazit plný text záznamu View this record from Arxiv