JSM2026
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Contributed Papers

Clinical Trial Monitoring, QTLs, Design and & Decision Tools

Tue, Aug 4, 10:30 AM - 12:20 PM Room CC-256 Thomas M. Menino Convention & Exhibition Center
David LiChair
Biopharmaceutical Section

7 Presentations

A Bayesian Approach for Monitoring Quality Tolerance Limits (QTLs) in Clinical Trials
10:35 AM - 10:50 AM
Joseph Poythress (Astellas Pharma)
good clinical practicerisk-based monitoringquality tolerance limitsstatistical process controlBayesian posterior probability
A New Approach to Clinical Trial Quality Tolerance Limits in Risk-Based Quality Management
10:50 AM - 11:05 AM
Steven Gilbert
ICH E6Discrete Survival AnalysisCUSUMSequential TestingQTLQuality Tolerance Limits
Clinical Monitoring Using Indirect Conditional Power
11:05 AM - 11:20 AM
Zejiang Yang (Syneos Health)
Co-authors: Xiaoqiang Xue (Syneos Health)
Conditional PowerPrimary endpointSurrogate endpointAdaptive designSimulation
Comparison of Applied SMART Designs and Existing Methodology: A Review
11:20 AM - 11:35 AM
Holly Hartman (Case Western Reserve University)
Co-authors: Zhengxi Chen (Case western Reserve University), Kathryn Menta (University of Missouri, Kansas City), Olivia Lindberg (Penn State)
SMARTclinical trialsreviewadaptive designs
Data Maturity Projection for Clinical Trial Monitoring using Monte Carlo Simulations
11:35 AM - 11:50 AM
Ding Jiang (Bristol Myers Squibb)
Co-authors: Ming Zhou (Bristol-Myers Squibb Company)
Trial monitoringDuration of responseData maturityMonte Carlo Simulation
Optimizing Quality Tolerance Limits Monitoring in Clinical Trials Through Machine Learning Methods
11:50 AM - 12:05 PM
Liwen Wu (Takeda Pharmaceuticals)
Good clinical practiceMachine learningQuality tolerance limitsRisk-based monitoring
Using Counterfactual Simulation to Decide on a Futility Rule in Group Sequential Designs
12:05 PM - 12:20 PM
Byron Gajewski (University of Kansas Medical Center)
Co-authors: Scott Berry (Berry Consultants)
posterior predictive probabilityprobability of future successalpha-spendingBayesianfrequentist
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