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.
@article{arxiv.2005.10248,
title = {Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic},
author = {R. Daniel Meyer and Bohdana Ratitch and Marcel Wolbers and Olga Marchenko and Hui Quan and Daniel Li and Chrissie Fletcher and Xin Li and David Wright and Yue Shentu and Stefan Englert and Wei Shen and Jyotirmoy Dey and Thomas Liu and Ming Zhou and Norman Bohidar and Peng-Liang Zhao and Michael Hale},
journal= {arXiv preprint arXiv:2005.10248},
year = {2020}
}
Comments
Accepted for publication in Statistics in Biopharmaceutical Research. 40 pages