Title: Estimands and Sensitivity Analysis in Clinical Trials
Date and Time: July21, 2021 11:00am to 12:30pm US ET
The DIA Statistics and Data Science Community is pleased to announce a new webinar on Estimands and Sensitivity in Clinical Trials.
Abstract:
Regulatory agencies including both the EMA and the FDA have published the ICH E9 (R1), addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. Frequent interactions between regulators and sponsors are necessary to ensure appropriate implementation of important principles. In this webinar, speakers from the industry and the regulatory agencies will share their perspectives in constructing the estimand framework in clinical trials, and their experiences in communicating with sponsors and with regulators.
Provisional programme is as follows:
Presentation 1
Craig Mallinchrodit (Biogen)
Communicating and Aligning Estimands in The ICH E9 (R1) Framework
https://link.springer.com/article/10.1007/s43441-019-00065-7
Presentation 2
Yongming Qu (Eli Lilly)
Implementation of ICH E9 (R1): A Few Points Learned During the COVID 19 Pandemic
https://link.springer.com/article/10.1007/s43441-021-00297-6
Panel Session
Rob Hemmings (Consilium Salmonson and Hemmings), Robert Temple (FDA/CDER), and John Scott (FDA/CBER)
We hope you can join us for this interesting session. To register for this event please use the link below
Registration
https://diaglobal.zoom.us/webinar/register/WN_sW_p9FODSJmmxv8vJ-r-Fg
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https://link.springer.com/article/10.1007/s43441-019-00065-7
https://link.springer.com/article/10.1007/s43441-021-00297-6
https://diaglobal.zoom.us/webinar/register/WN_sW_p9FODSJmmxv8vJ-r-Fg