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Session 8: ICH Guidance Updates – Part 1
Session Chair(s)
Jerald Schindler, DrPH
Chief Executive Officer
Strategic Statistics, United States
Aloka Chakravarty, PhD
Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
An Addendum was proposed to provide clarification on E9 and an update on the choice of estimand in clinical trials to describe an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. This Addendum is proposed to focus on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. While a variety of mid-stage and late-stage clinical trials may be in scope, the primary focus of the Addendum will be on confirmatory clinical trials. It will promote harmonized standards on the choice of estimand in clinical trials and describe on agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. In this session, you will be able to hear firsthand from the Topic Leader, Dr. Estelle Russek Cohen followed by a panel discussion in which key players in this initiative will share their insight. Ample time will be left to allow a robust floor discussion.
Speaker(s)
E9: Addendum to Statistical Principles for Clinical Trials: Missing Data, Estimands and Sensitivity Analysis
Estelle Russek-Cohen, PhD
FDA, United States
Senior Advisor, Office of Biostat
Speaker
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Q&A Panel Discussion - Joining the Speakers
Thomas J. Permutt, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
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