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Contributed Papers

Master Protocols: Streamlining Clinical Trial Designs

Wed, Aug 6, 2:00 PM - 3:50 PM Room CC-103B Music City Center

Zoran AntonijevicChair

Biopharmaceutical Section

5 Presentations

Bayesian Basket Trial Design in Early Oncology: A Practical Local Power Prior Framework

2:05 PM - 2:20 PM

Co-authors: Haiming Zhou (Daiichi Sankyo, Inc.), Haiming Zhou (Daiichi Sankyo, Inc.), Rex Shen, Sutan Wu, Philip He (Daiichi Sankyo Inc.)

Bayesian basket trial design Local power prior Dynamic borrowing Early oncology

Biomarker Driven Response Adaptive Platform Trials

2:20 PM - 2:35 PM

Co-authors: Spencer Woody (Amgen Inc), Qing Liu (Amgen Inc.), Spencer Woody (Amgen Inc)

adaptive design multiple testing master protocol precision medicine

Leveraging Historical Data to Evaluate an Intervention in a Pragmatic Cluster-Randomized Trial

2:35 PM - 2:50 PM

Co-authors: Tanvi Mehta (University of Minnesota), Tanvi Mehta (University of Minnesota), Caitlin Ward (University of Minnesota), Deborah Pestka (University of Minnesota), Timothy Beebe (University of Minnesota), Genevieve Melton (University of Minnesota), Ivana Ninkovic (Fairview Health Services), Zachary Kaltenborn (University of Minnesota), Joseph Koopmeiners (University of Minnesota)

dynamic borrowing hierarchical modeling Bayesian model averaging cluster randomized trial biostatistics

Master Protocols: Your Focus May Need More Focus

2:50 PM - 3:05 PM

Co-authors: Melissa Spann (Cytel Inc.), Melissa Spann (Cytel Inc.)

master protocol clinical trial design

Synergy-Informed Design of Platform Trials for Combination Therapies: False Positive Control, Allocation Optimization, and Sample Size Determination

3:05 PM - 3:20 PM

Co-authors: Nan Xi, Man Jin (AbbVie), Nan Xi, Lin Wang (Purdue University), Xin Huang (AbbVie Inc.)

Drug combination Multi-arm combination trials Synergy modeling Monte Carlo simulation Generalized Dunnett framework Multiple false positives

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