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
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 Strategy 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 intercurrent events and their corresponding implications.
Join us for a complimentary virtual panel discussion with regulatory and industry experts, who will be giving:
- A short presentation on Estimands in Oncology Trials
- A discussion on the issues around the practical implementation of the Estimand framework in Oncology
Click here for additional information and registration details.
