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.
no code implementations • 21 May 2020 • R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers, Olga Marchenko, Hui Quan, Daniel Li, Chrissie Fletcher, Xin Li, David Wright, Yue Shentu, Stefan Englert, Wei Shen, Jyotirmoy Dey, Thomas Liu, Ming Zhou, Norman Bohidar, Peng-Liang Zhao, Michael Hale
The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials.