Poster Session I -- RISW 2025

01: Asthma Lung Function AI Digital Twin to Improve the Lung Function Decline Prevention Study Efficiency

5:45 PM - 6:30 PM

Co-authors: Weishen Pan (Cornell University), Yifan Zhu (Sanofi), Md Akhtar Hossain (Sanofi US), Megan Hardin (Sanofi US), Lucia De Prado Gomez (Sanofi US), Mei Zhang (Sanofi-Aventis), Jun Xing (Sanofi US), Fei Wang (Cornell University), Zhaoling Meng (Sanofi US)

AI Digital Twin Asthma Lung Function Autoregressive Predictive Model Clinical Trial

02: A Commensurate Prior Model With Random Effects for Survival and Competing Risk Outcomes to Accommodate Historical Controls

5:45 PM - 6:30 PM

Co-authors: Manoj Khanal, Kwang Woo Ahn (Medical College of Wisconsin), Anjishnu Banerjee, Xi Fang (Medical College of Wisconsin), Brent Logan (Medical College of Wisconsin)

borrowing from historical data commensurate prior Dirichlet process matching

03: Bayesian Prediction of Event Times using Mixture Model for Blinded Randomized Controlled Trials

5:45 PM - 6:30 PM

Co-authors: Dan Zhao (Servier), Jingyan Fu (Rice University), Donia Skanji (Servier), Hua Liu (Servier), Rui (Sammi) Tang (Astellas), Ying Yuan (The University of Texas MD Anderson Cancer Center)

Bayesian model Event prediction Mixture Model Label-Switching Time-to-Event Endpoints

04: Addressing Multi-stage Selection Bias in Estimating Population-level Treatment Effects: A Weighted Multistate Modeling Approach

5:45 PM - 6:30 PM

Co-authors: Guannan Chen, Qing Pan (George Washington University), Li Cheung (National Cancer Institute)

Multistate models Inverse probability weighting Selection bias Population-level treatment effects Survival analysis Causal inference

05: Robust Covariate Adjustment for Randomized Clinical Trials when Covariates are Missing

5:45 PM - 6:30 PM

Co-authors: Jiaheng Xie

imputation missing covariates randomized clinical trials robust

06: Roche's First End-to-End R Journey to Submission

5:45 PM - 6:30 PM

Co-authors: Jingyuan Chen (Roche/Genentech), Ning Leng (Genentech, Inc. (A Member of the Roche Group))

End to End R Submission

07: Advanced Methods and Practical Considerations in the Use of Early Endpoints for Regulatory Decisions

5:45 PM - 6:30 PM

Co-authors: Xiaoyan Yin (FDA), Jing zhang (FDA)

Early Endpoint Accelerate approval Visual analytics Association analysis Meta analysis Machine learning method

08: An Adaptive Two-stage Mimicry Test for Immuno-oncology Products with Expectations of Proportional Hazards Violation

5:45 PM - 6:30 PM

Co-authors: Shogo Nomura (University of Tokyo), Yukino Umeki

adaptive designs survival data clinical trials weighted log-rank tests interim analysis

09: Assessment of Unequal Randomization in Clinical Trial Design

5:45 PM - 6:30 PM

Co-authors: Yuanyuan Han (Bristol Myers Squibb)

Unequal randomization Optimal randomization ratio Probability of success

10: Bayesian Basket Trial Design in Early Oncology: A Practical Local Power Prior Framework

5:45 PM - 6:30 PM

Co-authors: Haiming Zhou (Daiichi Sankyo, Inc.), Rex Shen, Sutan Wu (Daiichi Sankyo), Philip He (Daiichi Sankyo Inc.)

Bayesian basket trial design Local power prior dynamic borrowing early oncology

11: Combining Adaptive Phase II/III Designs with Dose Selection and Group Sequential Analysis for Time-to-Event Endpoints in Oncology Trials

5:45 PM - 6:30 PM

Co-authors: Wentian Guo

Seamless phase II/III design Dose optimization Combination p-value statistics Closed testing procedure Group sequential analysis Multiplicity control

12: Demo: Dose Exploration, Monitoring, and Optimization Using Biological and Clinical Outcomes

5:45 PM - 6:30 PM

Co-authors: Cheng-Han Yang (University of Texas Health Science Center at Houston)

Bayesian Adaptive Design Biomarker Dose Optimization Immunotherapy Targeted Agents

13: Statistical Methods for Leveraging External Controls in Cardiovascular Outcome Trials

5:45 PM - 6:30 PM

Co-authors: Will Landau (Eli Lilly and Company), Grace Rhodes (Eli Lilly and Company), Michael Sonksen, Karen Price (Eli Lilly and Company), Mingyang Shan (Eli Lilly and Company)

External Controls Bayesian Dynamic Borrowing Cardiovascular Outcome Trial

14: Using Simulation to Determine the Sample Size of a Randomized Controlled Trial Using Marginal Treatment Effects

5:45 PM - 6:30 PM

Co-authors: Scott Grey (Uniformed Services University of the Health Sciences), Seth Schobel-McHugh (Surgical Critical Care Initiative (SC2i), Uniformed Services University of the Health Sciences), Eric Elster (Surgical Critical Care Initiative (SC2i), Uniformed Services University of the Health Sciences)

Marginal Treatment Effects Sample Size Power calculation Randomized controlled trials (RCTs)Baseline covariates Population-averaged causal estimands

15: Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials

5:45 PM - 6:30 PM

Co-authors: Jialu Wang (Vertex Pharmaceutical), Yeh-Fong Chen (FDA), Thomas Gwise

adaptive clinical trial composite endpoints enrichment strategy win ratio method

16: Evaluating Wei's Urn Randomization in Early-Phase Oncology Trials

5:45 PM - 6:30 PM

Co-authors: Yan Wang (Exelixis)

Randomization Method Urn Design Small Sample Design Cohort Expansion Study Project Optimus

17: Differential Item Functioning (DIF) by Sex of the Kessler Psychological Distress Scale (K6) Among Adults with Cancer Using National Health Interview Survey

5:45 PM - 6:30 PM

Co-authors: Wei Liu (Phastar), Madeline Horan (Wake Forest University School of Medicine), I-Chan Huang (St Jude Children’s Research Hospital)

Differential Item Functioning (DIF)Kessler Psychological Distress Scale (K6)National Health Interview Survey (NHIS)Graded Response Model (GRM)Likelihood Ratio Test (LRT)Monte Carlo (MC) simulations

18: Statistical Approaches to Evaluate the Positive Control Drug using the hERG Assay

5:45 PM - 6:30 PM

Co-authors: Yu-Ting Weng (FDA), Dalong Huang (FDA/CDER)

hERG safety assay ICH E14 S7b equivalence testing

19: Covariate Adjustment Methods for Time-to-Event Outcomes in Randomized Trials: Accounting for Prognostic and Predictive Biomarkers

5:45 PM - 6:30 PM

Co-authors: SIYAO LI, Chen Hu (Johns Hopkins University)

Survival Analysis Restricted Mean Survival Time Hazard Ratio Cox Regression Randomized Clinical Trials

20: Application of Neural Networks in Longitudinal Patient-Reported Outcomes Data

5:45 PM - 6:30 PM

Co-authors: Ruoyu He, Xiaofei Hu (AbbVie), xiaoqiang wu, Yang Yang (AbbVie)

Longitudinal data Neural networks Patient-reported Outcomes GLMM

21: A Hierarchical Bayesian Borrowing Framework for Augmenting Clinical Trials Using External Data with Covariate and Outcome Shifts

5:45 PM - 6:30 PM

Co-authors: Lang Lang (Johns Hopkins University), Yanxun Xu (Johns Hopkins University), Shouhao Zhou (Penn State University), Qiuxin Gao (Johns Hopkins University)

Clinical Trial Bayesian Analysis Real Word Data

22: Adaptive-TMLE for the Average Treatment Effect based on Randomized Controlled Trial Augmented with Real-World Data

5:45 PM - 6:30 PM

Co-authors: Sky Qiu, Mark Van Der Laan (UC Berkeley), Jens Tarp (Novo Nordisk), Lars van der Laan (University of Washington)

TMLE Data Fusion Real World Data

23: Decision Making Using Median Time To Event : A Statistical Evaluation

5:45 PM - 6:30 PM

Co-authors: Danny Lu (Astrazeneca), Michael Pluta (Astrazeneca), Baisong Huang (AstraZeneca)

Go/No-Go Early Development Time-to-event

24: Innovative Bayesian Dynamic Borrowing Methods for Leveraging Multiple External Controls in Randomized Clinical Trials

5:45 PM - 6:30 PM

Co-authors: Peijin Wang (Duke University School of Medicine Dept. of Biostatistics & Bioinformation), Hwanhee Hong

external control meta-analytic predictive prior prior-data conflict robustness

25: Nonparametric Bayesian Approach for Borrowing Latent Subpopulation from External Data in Randomized Controlled Trials

5:45 PM - 6:30 PM

Co-authors: Tomohiro Ohigashi (Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science)

external data hybrid control nonparametric Bayesian

26: Quantifying the Impacts of RWD-related Biases due to Misclassification and Unmeasured Confounding for Bayesian Borrowing

5:45 PM - 6:30 PM

Co-authors: Angela Zhu (Boehringer Ingelheim), Matthew Valko, Dooti Roy (Boehringer Ingelheim Pharmaceuticals, Inc.), Mitchell Thomann (Boehringer Ingelheim), Victoria STRAUSS (Boehringer Ingelheim Pharma GmbH & Co KG)

real world data misclassification bias propensity score weighting meta-analytic predictive priors external controls

27: Sensitivity Analysis for Unmeasured Confounding in Estimating Individualized Treatment Regimens (ITR) in Real World Data

5:45 PM - 6:30 PM

Co-authors: Runjia Li (Eli Lilly and Company)

Sensitivity analysis Individualized treatment regimens Unmeasured confounding Real-world data Bayesian additive regression trees Precision medicine

28: Missing Data in Ambulatory Blood Pressure Monitoring (ABPM) Studies

5:45 PM - 6:30 PM

Co-authors: Xutong Zhao (FDA), Xutong Zhao (FDA), Runqiu Wang (University of Nebraska Medical Center), Yu-Ting Weng (FDA), Dalong Huang (FDA/CDER)

missing data safety Ambulatory Blood Pressure Monitoring multiple imputation inverse probability weighting

29: Quantitative Modeling and Statistical Analysis to Determine the Immunogenicity Triggering Threshold of Peptide Impurities in Generic Protein Therapeutics

5:45 PM - 6:30 PM

Co-authors: Puranjan Ghimire

30: Meta-analysis of Moxifloxacin Concentration-QTc Effects with Application to Assay Sensitivity Assessment

5:45 PM - 6:30 PM

Co-authors: Dalong Huang

assay sensitivity concentration-QTc models exposure-response relationship meta-analysis tolerance interval

Poster Session I

30 Presentations