Estimands in Hematologic Oncology Trials

no code implementations • 1 Oct 2020 • Steven Sun, Hans-Jochen Weber, Emily Butler, Kaspar Rufibach, Satrajit Roychoudhury

The estimand framework included in the addendum to the ICH E9 guideline facilitates discussions to ensure alignment between the key question of interest, the analysis, and interpretation.

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

Integrating Phase 2 into Phase 3 based on an Intermediate Endpoint While Accounting for a Cure Proportion

1 code implementation • 4 Jan 2019 • Kaspar Rufibach, Dominik Heinzmann, Annabelle Monnet

Planning for such an interim can be interpreted as making a randomized Phase 2 trial a part of the pivotal trial: if stopped at the interim, the trial would fully read out and a decision on a subsequent Phase 3 trial would be made.

Applications