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421 * ! Thu, 8/12/2021, 4:00 PM - 5:50 PM Virtual
Statistical Challenges Linked to Estimands of Interest: Leaving No Stone Unturned — Invited Papers
Biopharmaceutical Section, ENAR, Biometrics Section
Organizer(s): Pilar Lim, Janssen Research & Development, LLC; Elena Polverejan, Janssen Research & Development, LLC
Chair(s): Elena Polverejan, Janssen Research & Development, LLC
4:05 PM The Only Missing Data Left in Town? Study Withdrawals and the Treatment Policy Approach
Siying Sylvia Li, IQVIA; Michael O'Kelly, IQVIA
4:30 PM The Role of Hypothetical Estimand Strategies in Clinical Trials
Frank Bretz, Novartis AG; Mouna Akacha, Novartis
4:55 PM Does This Treatment Cause That Outcome?
Stephen J Ruberg, Analytix Thinking, LLC
5:20 PM Discussant: H. M. James Hung, U.S. Food and Drug Administration (FDA)
5:45 PM Floor Discussion