Poster Session I -- RISW 2026

A Bayesian Beta-Binomial Graphical Model for Multiregional Pain Assessment

5:45 PM - 6:30 PM

Co-authors: Yanxi Liu (Johns Hopkins University), Martin Lindquist (Johns Hopkins University)

Beta-binomial Graphical Model Bayesian Zero-Inflation Michigan Body Map Chronic Pain

A Bayesian Regression Model for Testing Proportionality of Average Release Rates for Topical Dermatological Products

5:45 PM - 6:30 PM

Co-authors: Elena Rantou (FDA/CDER), Siwei Zhang (Eli Lilly), Erica Su (FDA), Jeongsook Kim (FDA/CDER), Stella Grosser (FDA/CDER)

In Vitro Release Test Bioequivalence Poisson Regression Bayesian Regression Model

A CV-TMLE Global Test Approach to Multiple-Component Endpoints in Rare Disease Clinical Trials

5:45 PM - 6:30 PM

Co-authors: Tianyue Zhou, Susan Gruber (TLrevolution), Hana Lee (Food and Drug Administration), Wonyul Lee (FDA Center for Drug Evaluation and Research (CDER)), Lei Nie (The US FDA), Mark Van Der Laan (UC Berkeley)

CV-TMLE Global Test Composite Endpoint Rare Disease

A General Framework for Inference After Record Linkage

5:45 PM - 6:30 PM

Co-authors: Martin Slawski (George Mason University), Priyanjali Bukke (University of Virginia)

Record Linkage Linkage Errors Post-Linkage Inference Secondary Analysis Data Integration Statistical Software

A generalized synthetic control algorithm for sparse functional data

5:45 PM - 6:30 PM

Co-authors: Lucy Shao (UC San Diego, Department of Family Medicine & Public Health), Kilian Pohl (SRI International & Stanford University), Wesley Thompson (Center for Population Neuroscience and Genetics, Laureate Insitute for Brain Research)

synthetic control functional data analysis irregular sampling causal inference Bayesian modeling

A Nonparametric Bayesian Local-Global Model for Enhanced Adverse Event Signal Detection in Spontaneous Reporting System Data

5:45 PM - 6:30 PM

Co-authors: Xinwei Huang (University at Buffalo), Saptarshi Chakraborty (University At Buffalo)

pharmacovigilance real-world evidence adverse event signal detection Bayesian hierarchical model non parametric Bayesian models Dirichlet process prior

A Novel Causal Machine Learning Approach to Study Threshold Effects of Continuous Exposure Using Multi-Source Linked Medicare Claims Data

5:45 PM - 6:30 PM

Co-authors: Haoyu Ren

Causal inference continuous exposure HTE (Heterogeneity treatment effect)Changing point Machine learning

A Platform Clinical Study in Medical Devices to Accelerate Identification of Novel Myopia-Correcting Soft Contact Lenses

5:45 PM - 6:30 PM

Co-authors: Wright Shamp (Johnson & Johnson), Cristiana Mayer, Oksana Sova (Johnson & Johnson)

platform trial medical devices statistical and operational efficiencies feasibility phase of medical devices accelerate decision making on prototypes master protocol

A Reparameterized Illness-Death Model for Simulating Correlated Progression-Free Survival and Overall Survival

5:45 PM - 6:30 PM

Co-authors: Han Zhang (Astellas)

Clinical trial simulation Progression-free survival and overall survival Illness-death model TrialSimulator

A Rolling Platform Framework for Mid-Trial Addition of a Combination Arm with Strong FWER Control

5:45 PM - 6:30 PM

Co-authors: bo zhang, Haitao Pan (St. Jude Children's Research Hospital), Yisheng Li (University of Texas MD Anderson Cancer Center)

Platform design strong control FWER Dunneet correlation order-restricted inference group sequential spending

A two-stage dose optimization framework for oncology drug development with multiple efficacy and safety endpoints via an integrated benefit-risk assessment

5:45 PM - 6:30 PM

Co-authors: Shubhadeep Chakraborty (Bristol Myers Squibb), Abhishek Dubey (Bristol Myers Squibb Company), Arun Kumar (Bristol Myers Squibb), Ivan Chan (Bristol Myers Squibb)

Benefit-risk assessment Dose selection Optimal biological dose Oncology drug development

Adaptive designs in trials with time-to-event endpoints and covariate adjustment

5:45 PM - 6:30 PM

Co-authors: Daniel Backenroth, Ting Ye (University of Washington)

covariate adjustment information monitoring time-to-event data adaptive designs

Adaptive Regional Selection in Multi-Regional Clinical Trials: An Interim Analysis–Based Screening Design

5:45 PM - 6:30 PM

Co-authors: Chinfu Hsiao (National Health Research Institutes), Chieh Chiang (Tamkang University)

Multi-regional clinical trials adaptive design regional heterogeneity futility threshold

Adaptive Seamless Phase 2/3 Designs with Contribution of Components Demonstration

5:45 PM - 6:30 PM

Co-authors: Xiaohan Guo (Pfizer Inc.), Ruoqi Song, Biao Xing (Pfizer), Christophe Le Corre (Pfizer), Edward Mayerson (Seagen), Haitao Chu (Pfizer), Diqiong Xie (Seagen), Ray Li, Yiyi Chen (Pfizer)

Adaptive design Combination therapy Contribution of components (CoC)Graph-based multiple testing

Addressing Confounding by Indication in Learn-As-you-GO (LAGO) Trials Through (Un)Measured Center Characteristics

5:45 PM - 6:30 PM

Co-authors: Minh Thu Bui

adaptive clinical trials dependent samples implementation trial large-scale intervention trial unmeasured confounding public health

Automated generation of SAP multiplicity appendices via the appendMCP R package

5:45 PM - 6:30 PM

Co-authors: Yevgen Tymofyeyev (Johnson & Johnson), Michael Grayling (Johnson & Johnson)

Graphical multiple comparison procedures (MCP)Group‑sequential design (GSD)Statistical Analysis Plan (SAP) automation R package: appendMCP Design operating characteristics

Benefit:Risk Assessment in Clinical Trial Monitoring Using a Repeated Prediction Interval Approach

5:45 PM - 6:30 PM

Co-authors: Lizhao Ge (George Washington University), Qihang Wu (The George Washington University), Scott Evans (George Washington University), Toshimitsu Hamasaki (George Washington University)

DSMB Benefit:risk Prediction intervals Interim Analyses

CITIES 2.0: An Easier Way to Simulate Clinical Trials Accounting for Intercurrent Events

5:45 PM - 6:30 PM

Co-authors: Ahmad Hakeem Abdul Wahab (Johnson & Johnson)

Estimand Intercurrent Events Missing Data Shiny R package treatment policy

Design Guidance for Correlated Dual Endpoint Trials Using a Multi-State Model

5:45 PM - 6:30 PM

Co-authors: Liping Huang (Bristol Myers Squibb), Hsin-Yu Lin (Bristol Myers Squibb), Kaushal Mishra, Marzana Chowdhury (Bristol Mayers Squibb), Archie Sachdeva, Dingning Liu (University of California, Davis), Stephanie Meadows-Shropshire (Bristol Myers Squibb), Shiqi Dong (Bristol Myers Squibb)

Multistate model Optimal alpha split Correlated dual endpoints Overall survival Progression-free survival

Digital Twin-Enabled Clinical Trials: A Framework for Leveraging Real-World Data and Causal Machine Learning to Enhance Trial Efficiency and Decision-Making

5:45 PM - 6:30 PM

Co-authors: Meizi Liu (Takeda)

Digital twins causal machine learning real-world data Bayesian adaptive design synthetic control arms

Estimating and Calibrating the Bayesian Probability of Preclinical Stage-Gate Success from Heterogeneous Evidence

5:45 PM - 6:30 PM

Co-authors: Yue Yang (Takeda), Masanao Yajima (Boston University), Steven Novick (Takeda)

Go/No-Go Decisions Bayesian Decision Theory Multi-Endpoint Drug Discovery Preclinical Stage-Gate Decision

Estimating Treatment Efficacy in LTE Studies: A Novel Front-Door Causal Inference Approach Leveraging Validated Mediators

5:45 PM - 6:30 PM

Co-authors: Yuqian Shen, Anna Guo (Emory University), Ahrim Youn (Sanofi), Qi Zhang (Sanofi), Yingwen Dong (sanofi), Nicholas Cullen (Sanofi), Marek Demissie (Sanofi)

Causal inference Front-door model Unmeasured confounding Mediator validation External control arm

Evaluating Post-Progression Survival in the Context of Progression-Free Survival Benefits: A Revisit of the CodeBreaK200 Design

5:45 PM - 6:30 PM

Co-authors: Zhoujingpeng Wei Wei (University of Wisconsin - Madison), Yuanyuan Han (Bristol Myers Squibb), Luoying Yang (Bristol-Myers Squibb), Pourab Roy (Regeneron), Chunsheng He (Bristol-Myers Squibb), Liangang Liu, Shu-Pang Huang (NCSU), Hsin-Ju Hsieh (AstraZeneca)

Oncology trials Post-progression survival Overall survival Progression-free survival Crossover Informative censoring

Evolving Longitudinal Patient Histories and Re-enrollment in Master Protocol Trials

5:45 PM - 6:30 PM

Co-authors: Shiyu Wan, Yuhan Qian (University of Washington), Yanyao Yi (Eli Lilly and Company), Nicole Hamblett (Children's Hospital), patrick heagerty (University of Washington), Ting Ye (University of Washington)

Causal inference Covariate adjustment Estimands Inverse probability weighting Platform trials

Innovative DO+CoC Design Strategies for Drug Combinations: Integrating Dose Optimization, Contribution of Components, and Stage‑Bridging Analytics

5:45 PM - 6:30 PM

Co-authors: Yu Wang (Bristol Myers Squibb)

Drug Combinations Contribution of Components Dose Optimization Clinical Trial Designs Bayesian Methods

On the Calibration of Bayesian Success Criteria and Operating Characteristics for Clinical Trials

5:45 PM - 6:30 PM

Co-authors: Li Wang (AbbVie), Peng Yang (MD Anderson Cancer Center), Ying Yuan (The University of Texas MD Anderson Cancer Center)

Bayesian design Clinical trials Error control Operating characteristics

Propensity Score-Integrated Bayesian Semiparametric Meta-Analytic-Predictive Borrowing for Hybrid Control Designs

5:45 PM - 6:30 PM

Co-authors: Zihang Zhong (Nanjing Medical University), Jingwen Zuo (Nanjing Medical University), Ruyu Huang, Hui Yu (Nanjing Medical University), Jingwei Wu (Temple University), Hao Yu (Nanjing Medical University), Jianling Bai (Nanjing Medical University)

Hybrid control Propensity score Meta-analytic-predictive prior Bayesian semiparametrics Information borrowing

Qualification of WHO Risk Drinking Level Reduction as an Efficacy Endpoint for Alcohol Use Disorder Trials

5:45 PM - 6:30 PM

Co-authors: Sue-Jane Wang (FDA/Office of Biostatistics, Office of Translational Sciences, CDER), Jing Han (FDA), Minjeong Park (FDA), Ruihan Lu, Weimeng Wang (FDA Center for Drug Evaluation and Research (CDER)), Laura Lee Johnson (FDA), Naomi Knoble (FDA), Maryam Afshar (FDA)

alcohol use disorder surrogate endpoint patient-focused drug development regulatory statistics drug development tool endpoint qualification

RESOLVE-IPD: High-Fidelity Individual Patient Data Reconstruction and Uncertainty-Aware Subgroup Meta-Analysis

5:45 PM - 6:30 PM

Co-authors: Lang Lang (Johns Hopkins University), Yao Zhao, Qiuxin Gao (Johns Hopkins University), Yanxun Xu (Johns Hopkins University)

Survival Analysis KM IPD Reconstruction Uncertainty Quantification Meta Analysis

“6 choose 4”: Strategies for overall survival safety monitoring

5:45 PM - 6:30 PM

Co-authors: Paloma Hauser (Genentech), Godwin Yuen Yung (Genentech), Kaspar Rufibach (Merck KGaA), Marcel Wolbers (Roche), Mark Yan, Jue Wang (Roche)

chronic disease indolent cancers intermediate outcome oncology clinical trial surrogate endpoint survival detriment

Poster Session I

30 Presentations