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Contributed Papers

Time to Event and Composite Endpoint Applications in Clinical Trials

Wed, Aug 9, 10:30 AM

Ruvie MartinChair

Biopharmaceutical Section

7 Presentations

Accelerate Multiple Myeloma Clinical Trials with Covariate Adjustment

10:35 AM - 10:50 AM

Md Shamsuzzaman

Co-authors: Zhenjun Ma, Sanhita Sengupta (Bristol Myers Squibb), Min Chen, Ivan Chan (Bristol Myers Squibb)

Consideration of Stratification in Confirmatory Trials with Time-to-Event Endpoint

10:50 AM - 11:05 AM

Co-authors: Yizhuo Wang (University of Michigan), Zifang Guo, Xiao Fang, Fang Liu, Liji Shen (Merck & Co., Inc.)

Estimating the PFS treatment effect in a dose ranging study accounting for dose reduction

11:05 AM - 11:20 AM

Zheng Li (Novartis Pharmaceuticals)

Co-authors: Ajmal Oodally (Novartis Pharmaceuticals), Arunava Chakravartty (Novartis Pharmaceuticals)

Quantify the likelihood of pivotal trial success based on early phase learning endpoints

11:20 AM - 11:35 AM

Co-authors: Godwin Yuen Yung (Genentech), Jue Wang (Genentech), Markus Niggli (Roche), Michelle Byrtek (Genentech)

The gold standard for measuring progressive diseases: combining outcomes by converting to time

11:35 AM - 11:50 AM

Samuel Dickson (Pentara)

Co-authors: Craig Mallinckrodt (Pentara Corp, Millcreek UT), Newman Knowlton (Pentara Corporation), Mitchell Wassom (Pentara Corporation), Suzanne Hendrix (Pentara Corporation)

Time-to-Event Analysis Approaches for Randomized Clinical Trials with Composite Endpoints

11:50 AM - 12:05 PM

Gregory Golm (Merck & Co., Inc.)

Co-authors: Devan Mehrotra (Merck & Co., Inc.), Rachel Marceau West (Merck & Co., Inc.)

Win Ratio and Meta-Analytical Methods to Evaluate Non-Proportional Treatment Effects in RCTs

12:05 PM - 12:20 PM

Stephanie Pan (Boston University)

Co-authors: Michael LaValley (Boston University)

Session participants

Elena Polverejan (Johnson & Johnson-Janssen R&D)

Participant

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