After the ICH introduction of the Estimand framework for clinical trials in ICH E9(R1), finalized in November 2019, regulatory authorities are requiring detailed Estimand statements in trial protocols. This requires the pre-definition of the four Estimand Attributes (treatment, patient population, variable, population-level summary) and the Estimand Strategies for addressing inter-current events. In Oncology studies, defining the Estimand framework for time to event endpoints is particularly challenging, for example due to different censoring strategies for inter-current events and their corresponding implications.

Watch this virtual panel discussion with regulatory and industry experts, who give:

• A short presentation on Estimands in Oncology Trials
• A discussion on the issues around the practical implementation of the Estimand framework in Oncology

Moderator:

James Matcham, Sr Principal, Strategic Consulting, Cytel and former VP Early Biometrics and Statistical Innovation, AZ

Panelists:

Michelle Casey, Executive Director of Biostatistics, Pfizer
Kaspar Rufibach, Biostatistician, Roche and member of the Estimands in oncology SIG sponsored by PSI and EFSPI
Rob Hemmings, Partner, Consilium and former Chair of CHMP SAWP and head of Statistics at MHRA
Andy Stone, Director, Stone Biostatistics
Paul Terrill, Principal, Strategic Consulting, Cytel