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Roundtable

TL01-07 Roundtable Discussions

Thu, Sep 17, 11:45 AM - 1:00 PM Room Forest Glen Bethesda North Marriott Hotel & Conference Center

7 Presentations

TL01: Master Protocols Beyond Oncology: Barriers, Opportunities, and Regulatory Expectations

11:45 AM - 1:00 PM

Co-authors: Bryan McComb (Pfizer)

Master protocols basket trials umbrella trials platform trials adaptive trial designs complex clinical trial designs

TL02: Designing Data Quality-responsive Protocols for Regulatory RWD Studies: A Practitioner Roundtable

11:45 AM - 1:00 PM

Co-authors: Brian Gillette (Droice Labs)

Data quality-responsive protocols Real-world data clinical trials Adaptive analytic design Quantitative bias analysis Data standards for RWD Regulatory RWE study design

TL03: Using Agentic AI to Support Clinical Trial Design: Real Use Cases, Successes, Challenges, and Open Questions

11:45 AM - 1:00 PM

Han Zhang (Astellas)

Co-authors: Ning Leng (Abbvie)

design agentic AI

TL04: Cutting Edge Immunotherapy Dose Finding in Autoimmune Disease

11:45 AM - 1:00 PM

Co-authors: Patricia Anderson (ICON)

autoimmune dose escalation dose finding early phase CAR T-cell CAR-T

TL05: Can AI Augment Endpoint Selection in Clinical Trial Design? From Fragmented Data to Statistically Defensible Recommendations

11:45 AM - 1:00 PM

Co-authors: Xiaoyan Wang (Tulane)

endpoint selection AI clinical trial design protocol development FDA/EMA Regulatory Interaction evidence synthesis

TL06 Bayesian Borrowing Methods for Extrapolation in Small-Sized Clinical Trials: Experience Sharing for Applications in Pediatric and Rare Diseases

11:45 AM - 1:00 PM

Xiaoxia Champon (North Carolina State University)

Co-authors: Fei Wu (FDA)

TL07: Practical Statistical Thinking for Vaccines Clinical Trials

11:45 AM - 1:00 PM

Co-authors: Wayne Woo (Novavax)

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