id author title date pages extension mime words sentences flesch summary cache txt cord-160526-27kmder5 Meyer, R. Daniel Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic 2020-05-21 .txt text/plain 9268 404 39 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. It should continue throughout the conduct of the study in light of the evolving situation and accumulating data, considering regional differences in the infection status and pandemic Determine what additional information needs to be collected in the study database or in the form of input from study investigators in order to adequately monitor, document, and address pandemic-related issues (feasibility to obtain such information and its quality may vary and this needs to be considered as part of the risk factors);  Understand reasons for treatment or study discontinuation and the impact on planned estimands and intercurrent events; ./cache/cord-160526-27kmder5.txt ./txt/cord-160526-27kmder5.txt