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Roundtable

TL04-06 Roundtable Discussions

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

3 Presentations

TL04: Adaptive Platform Trials: Lessons Learned and the Road Ahead

11:45 AM - 1:00 PM

Co-authors: Theis Lange (University of Copenhagen), Wenxin Zhang (UC Berkeley)

Adaptive platform trials Innovative/complex design AI/ML

TL05: Considerations of Dose Optimization in Oncology Drug Development

11:45 AM - 1:00 PM

Co-authors: Zheng Li (Novartis Pharmaceuticals)

dose optimization oncology seamless designs

TL06: Practical Considerations in Pivotal Trial Designs in Renal Diseases from both Industry and Regulatory Perspectives

11:45 AM - 1:00 PM

Lingling An (FDA)

Co-authors: Cassie Dong

surrogate endpoint estimand innovative trial design accelerated approval clinical trial design

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