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Roundtable

TL15-22 Roundtable Discussions

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

8 Presentations

TL15: From Innovation to Credibility: When Are AI and Real-World Data Ready for Regulatory Use in Oncology?

11:45 AM - 1:00 PM

Co-authors: Yishan Wang (Johnson & Johnson)

Real-World Evidence (RWE)Artificial Intelligence (AI)Oncology Drug Development Regulatory Decision-Making Causal Inference Data Quality and Bias

TL16: Use of Model-based Meta-Analysis (MBMA) to Better Integrate Multiple Data Sources in Drug Development

11:45 AM - 1:00 PM

Co-authors: Matt Zierhut (Certara), Jonathan French (Johnson & Johnson)

Meta-analysis External control arm Clinical trial simulation Go/no-go decisions

TL17: Using the Two-Stage Propensity Score Method to Estimate Medical Device Treatment Effects in Comparative Studies from Real World Data Sources.

11:45 AM - 1:00 PM

Co-authors: Rhoda Muse (FDA)

Real world data Causal treatment effect Propensity score

TL18: Navigating Statistical Review and Inspection of Real-World Evidence in Regulatory Submissions: A Practitioner Discussion

11:45 AM - 1:00 PM

Co-authors: Mayur Saxena (Droice Labs)

Real-world evidence Regulatory review and inspection Estimand derivation from RWD Quantitative bias analysis Data traceability and reproducibility Data standards for RWD

TL19: From Innovation to Implementation: What Limits the Impact of Quantitative Advances on Development Decisions?

11:45 AM - 1:00 PM

Co-authors: Yefei Zhang (Takeda pharmaceuticals)

Quantitative Decision-Making Innovative trial designs Implementation challenges and barriers Drug development

TL20: Towards Wider Implementation of Covariate Adjustment: SAP/Protocol Templates and Challenges to Adoption

11:45 AM - 1:00 PM

Daniel Backenroth

Co-authors: Leiya Han (PPD, Inc.)

covariate-adjustment in RCT protocol and statistical analysis plan language marginal and conditional estimands continuous endpoints binary endpoints time-to-event endpoints

TL21: Strategies to Help Statisticians Influence Interdisciplinary Team Decision-Making in the Drug Development Process

11:45 AM - 1:00 PM

Co-authors: Disa Yu (Sanofi)

Statistical influence Decision making Interdisciplinary team Drug development process Strategies for statistical influence

TL22: The Hidden Curriculum of Pharma: Helping Early Career Statisticians Thrive

11:45 AM - 1:00 PM

Co-authors: Simina Boca

Statistical leadership Career development Transdisciplinary quantitative decision-making

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