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Contributed Papers

Statistical Methods for Clinical Trial Endpoints

Mon, Aug 5, 2:00 PM - 3:50 PM

Elena RantouChair

Biopharmaceutical Section

6 Presentations

How to Plan an Early Futility Analysis using Intermediate Clinical Endpoints for Phase III Studies

2:05 PM - 2:20 PM

Mehreteab Aregay (AstraZeneca)

Co-authors: Euan Macpherson (AstraZeneca), Cathy Qi (AstraZeneca)

Power Considerations of Ordinal Composite Endpoints in Clinical Trials

2:20 PM - 2:35 PM

Co-authors: Dandan Liu (Vanderbilt University Medical Center)

Seamless phase 2/3 design with Bayesian dose selection rule based on primary and surrogate endpoints

2:35 PM - 2:50 PM

Pranav Yajnik (Cytel)

Co-authors: Thomas Brechenmacher (Cytel)

Total events as primary endpoints in cardiovascular outcome trials

2:50 PM - 3:05 PM

Co-authors: You Wu (Amgen), Anna McGlothlin (Berry Consultants), Todd Graves (Berry Consultants LLC), Elizabeth Lorenzi (Berry Consultants, LLC), Qing Liu (Amgen), Huei Wang (Amgen, Inc.)

Unified and Simple Sample Size Calculation for Cluster RCTs with Skewed or Ordinal Outcomes

3:05 PM - 3:20 PM

Shengxin Tu (Vanderbilt University)

Co-authors: Chun Li, Bryan Shepherd (Vanderbilt University, School of Medicine)

Validating accelerometry-derived gait and physical activity measures collected in-lab and at-home

3:20 PM - 3:35 PM

Nunzio Camerlingo (Pfizer)

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