36 citations · 40 across the 4 of their papers we have counts for
4 papers
The Role of Occlusion: Potential Extension of the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis for Time-to-Event Oncology Studies
Jonathan M Siegel, Hans-Jochen Weber, Stefan Englert
The ICH E9 (R1) Estimands Guidance1 terminology does not completely address the conceptual needs of time-to-event estimands in the complex oncology context. We previously described…
Time-to-event estimands and loss to follow-up in oncology in light of the estimands framework
Jonathan Siegel, Hans-Jochen Weber, Stefan Englert +1
Time-to-event estimands are central to many oncology clinical trials. The estimand framework (addendum to the ICH E9 guideline) calls for precisely defining the treatment effect of…
Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework
Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu +10
COVID-19 outbreak has rapidly evolved into a global pandemic. The impact of COVID-19 on patient journeys in oncology represents a new risk to interpretation of trial results and it…
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers +15
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. Th…