Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework

no code implementations • 8 Jun 2020 • Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu, Godwin Yung, Michelle Casey, Stefan Englert, Feng Liu, Yi Liu, Oliver Sailer, Jonathan Siegel, Steven Sun, Rui Tang, Jiangxiu Zhou

We identify key intercurrent events that may occur due to COVID-19 in oncology clinical trials with a focus on time-to-event endpoints and discuss considerations pertaining to the other estimand attributes introduced in the ICH E9 addendum.

valid