2022 Joint Fall Conference

Parallel Sessions: 

Session 1: On market approval and market access: statistical advancement in Health Technology Assessment

  • Indirect Treatment Comparison Methods in Health Technology Assessment Submissions (Slides)
  • Augmenting Phase 3 trials to generate the right evidence for HTAs at the right time (Slides)
  • European HTA Regulation: preliminary methodological considerations and evidence requirements (Slides)


Session 2: Strengthening Design and Inference from External Evidence Synthesis: Bayesian and Causal Inference Methods

  • Bayesian methods of borrowing study-level historical longitudinal control data for mixed-effects model with repeated measures (Slides)
  • A brief review of causal-inference methods for studies with intercurrent events (Slides)
  • Leveraging external evidence using Bayesian hierarchical model and propensity score in the presence of covariates (Slides)


Session 3: Real-World Evidence – From foundation supporting causal inference to applications in clinical development and regulatory decision-making

  • Advances in Causal Inference: Strengthening the Foundation (Slides)
  • Target population statistical inference with data integration across multiple sources (Slides)
  • Assessment of fit-for-use real-world data sources and applications (Slides)


Session 4: Complex and Innovative Clinical Trial Designs and Analysis Methods

  • Generalized Pairwise Comparisons: Toward Estimand-Centered Analysis (Slides)
  • Adaptive Designs Allowing for Mid-Term Modifications (Slides)
  • Efficient design and analysis of a Phase II dose-finding study with a binary efficacy endpoint (Slides)


Session 5: Innovative Design and Analytics for Clinical Trials and EHR Data

  • Natural language processing to identify lupus nephritis phenotype in electronic health records (Slides)
  • BOP2-DC: Bayesian optimal phase II designs with dual-criterion decision making (Slides)
  • Virtual control approaches for estimating treatment effect in single-arm clinical trials (Slides)


Session 6: Bayesian Approach to Early Phase Development in Oncology

  • Overview of Dose Escalation Design in Oncology (Slides)
  • gBOIN-ET: The generalized Bayesian Optimal Interval Design for optimal dose-finding for ordinal graded efficacy and toxicity in early clinical trials (Slides)
  • Constrained Hierarchical Bayesian Model for Latent Subgroups in Basket Trials with Two Classifier (Slides)


Session 7: Standing on the Shoulders of Giants: How to Become a Successful Statistician in the Pharmaceutical Industry

  • How to be a Drug Developer with statistical expertise (Slides)
  • Passion and Curiosity – A personal journey (Slides)
  • Influence a Cross-functional Team to Go Against Precedent (Slides)