RISW2025
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Roundtable

TL10-17 Roundtable Discussions

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

8 Presentations

TL10: Tipping Point Analyses for Time-to-Event Endpoints in Regulatory Submissions
11:45 AM - 1:00 PM
Philip He (Daiichi Sankyo Inc.)
Co-authors: Haiming Zhou (Daiichi Sankyo, Inc.)
Tipping point analysissensitivity analysisregulatory submissionsmissing dataoncology trials
TL11: Causal Artificial Intelligence and Machine Learning for Generating Regulatory-Grade Real-World Evidence
11:45 AM - 1:00 PM
Hana Lee (Food and Drug Administration)
Co-authors: Maya Petersen (University of California, Berkeley)
Causal InferenceMachine LearningArtificial IntelligenceReal World EvidenceImplementationRegulatory requirements
TL12: Modern Causal Inference in Non-Interventional Studies: Statistical & Methodologic Considerations
11:45 AM - 1:00 PM
Susan Gruber (TLrevolution)
Co-authors: Mark Van Der Laan (UC Berkeley)
Causal InferenceNon-Interventional StudiesTMLE (Targeted Maximum Likelihood Estimation)ConfoundingMissing data
TL13: The Role of Statisticians in Adapting to ICH E6(R3) Revision
11:45 AM - 1:00 PM
Co-authors: Justine Rochon (Boehringer Ingelheim Pharma GmbH & Co. KG)
ICH E6(R3) guidelineGood Clinical Practice (GCP)risk proportionalityfit-for-purposestatistical considerations and analysisessential records
TL14: Go/No-Go Decision-Making of Transitioning to Phase 3 Study in Clinical Development
11:45 AM - 1:00 PM
Annie Wang (Astellas Pharma)
Co-authors: Yusuke Yamaguchi (Astellas Pharma Global Development, Inc.)
Go/No-Go decision makingClinical trial design
TL15: Statistical Methods for Multi-Reader Multi-Case (MRMC) Data Analyses
11:45 AM - 1:00 PM
Co-authors: Tinghui Yu (AstraZeneca)
MRMCMedical imagingDiagnostics
TL16: Digital Biomarkers: The Final Frontier of Clinical Trials
11:45 AM - 1:00 PM
Co-authors: Raul Torres (Takeda)
digital biomarkersclinical trials
TL17: Is the Estimand Framework Useful for Safety Evaluation in Clinical Trials?
11:45 AM - 1:00 PM
Co-authors: Steven Sun
EstimandSafetyClinical trials
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