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366 * Thu, 8/12/2021, 12:00 PM - 1:50 PM Virtual
Trial Design and Analysis Methods for COVID-19 Treatment/Prevention — Invited Papers
ENAR, Biopharmaceutical Section, Biometrics Section, Caucus for Women in Statistics
Organizer(s): Michael Rosenblum, Johns Hopkins University
Chair(s): Bingkai Wang, Johns Hopkins Bloomberg School of Public Health
12:05 PM Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment for Binary, Ordinal, or Time-to-Event Outcomes
David Benkeser, Emory University; Ivan Diaz, Weill Cornell Medical College; Alex Luedtke, University of Washington; Daniel Scharfstein, University of Utah; Jodi Seagal, Johns Hopkins University; Michael Rosenblum, Johns Hopkins University
12:30 PM Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?
Cornelia Kunz, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany ; Silke Jörgens, Janssen-Cilag GmbH, Neuss, Germany ; Frank Bretz, Novartis AG; Nigel Stallard, The University of Warwick, Coventry, UK; Kelly Van Lancker, Ghent University, Belgium; Dong Xi, Novartis Pharmaceuticals, East Hanover, New Jersey, USA ; Sarah Zohar, Sorbonne Université, Paris, France; Christoph Gerlinger, Statistics and Data Insights, Bayer AG, Berlin, Germany ; Tim Friede, University Medical Center Göttingen, Göttingen, Germany
12:55 PM Challenges in clinical trial design during a pandemic: Experiences from the UK and beyond
Thomas Jaki, University of Cambridge
1:20 PM Discussant: Laura Lee Johnson, Center for Drug Evaluation and Research, U.S. FDA
1:40 PM Floor Discussion