Estimands in Oncology Virtual Panel Discussion

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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.

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

There will be an opportunity to ask questions both during and after the panel discussion.

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Register for the webinar today! If you cannot attend, please register and we will email you the webinar replay and slides.

Speakers

Click here to learn more about the speakers backgrounds and credentials

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

Register