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Roundtable

TL01-03 Roundtable Discussions

Thu, Sep 25, 11:45 AM - 1:00 PM Room Great Falls Bethesda North Marriott Hotel & Conference Center

3 Presentations

TL01: Statistical Considerations and Innovations in Seamless Designs to Accelerate Clinical Development

11:45 AM - 1:00 PM

Co-authors: Ran Liao

seamless Adaptive Optimization Benifit risk Transition strategies Regulatory compliance

TL02: Opportunities and Challenges in the Application of Modern Covariate Adjustment Methods

11:45 AM - 1:00 PM

Klaus Holst (Novo Nordisk)

Co-authors: Christian Pipper (Novo Nordisk A/S)

Covariate adjustment Precision boosting Prespecification Sample size reduction Regulatory acceptance Academic collaboration

TL03: Application of Dynamic Borrowing Method in Clinical Trial Designs

11:45 AM - 1:00 PM

Co-authors: Hao Sun (Bristol Myers Squibb)

Adaptive design Dynamic borrowing Bayesian clinical trial design

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