Poster Session II -- RISW 2026

A Bayesian Mediation Framework for Multilevel Functional Data: Results from the Sertraline/Placebo-Controlled EMBARC Study

9:45 AM - 10:30 AM

Co-authors: Annan Deng (New York University School of Medicine)

Mediation Analysis Bayesian Inference Causal Inference Functional Data Analysis Repeated Measures High-Dimensional Data

A Partially Linear Additive Single-index Threshold Model for Identification of Treatment-Sensitive Subsets based on Longitudinal Proportion Data

9:45 AM - 10:30 AM

Co-authors: Dongsheng Tu (Queen's University), YUWEI KE (Queen's University), Hok Kan Ling

Precision medicine Patient reported outcome Longitudinal data model Clinical trial data analysis

Advancing Global Regulatory Submissions through Next Generation Submission (NGS): A Collaborative Implementation Case Study

9:45 AM - 10:30 AM

Co-authors: Carrie Zhang (ClinChoice Inc.), Asif Karbhari (AstraZeneca)

None

AI-Assisted Bayesian Meta-Analysis Modeling of Drug Safety

9:45 AM - 10:30 AM

Co-authors: Christine Peterson (Rice University), Zihan Zhou, Le Bao (Penn State University), Shouhao Zhou (Penn State University)

Bayesian meta-analysis Incomplete reporting MAGEC Drug Safety Large Language Models

AI-Augmented Evidence Synthesis for Clinical Trial Design: Building a Multi-Source Trial Intelligence Framework in Rheumatoid Arthritis

9:45 AM - 10:30 AM

Co-authors: Xiaoyan Wang (Tulane), Xiaopeng Miao (Neurocrine Biosciences), Lerong Li, Mei Yang

AI large language models (LLMs)natural language processing (NLP)Clinical Trial Design rheumatoid arthritis (RA)evidence synthesis

An Evaluation Framework for Imputation Methods for Incomplete Multivariate Longitudinal Data: A Comparative Study of Real-World CAR-T Therapy Data

9:45 AM - 10:30 AM

Co-authors: Yein Jeon, Jordan Gauthier (Fred Hutchinson Cancer Center), Qian Wu (Fred Hutch)

Missing data Machine learning Longitudinal data Data imputation Method evaluation framework

An Interpretable Rate Summary for Competing Risks in Clinical Studies: The Average Sub-Hazard

9:45 AM - 10:30 AM

Co-authors: Xiang Meng (Dana-Farber Cancer Institute), Khondoker Nabi, Hajime Uno (Dana-Farber Cancer Institute)

Competing risks Incidence rates Survival analysis Nonparametric inference Clinical trials Subdistribution hazards

Baseline Adjustment in Pharmacogenomics: Distinguishing Total and Conditional Genetic Effects on Drug Response

9:45 AM - 10:30 AM

Co-authors: Yuhan Xie (Merck), Wujuan Zhong (Merck & Co., Inc.), Judong Shen (Merck & Co., Inc.)

baseline adjustment pharmacogenomics drug-response phenotypes

Bayesian Borrowing Methods for Pediatric Extrapolation in Non-malignant Hematological and Rare Disease Clinical Trials

9:45 AM - 10:30 AM

Co-authors: Xiaoyan Yin (FDA), Huan Wang (FDA)

Bayesian borrowing method Pediatric extrapolation Rare disease Non-malignant hematology External data

Bayesian Dynamic Borrowing for Multi-Endpoint Survival Trials Using Deep Neural Network

9:45 AM - 10:30 AM

Co-authors: Yunyi (Renie) Liu (UC San Diego, Department of Family Medicine & Public Health), Sonia Jain (University of California, San Diego)

Bayesian dynamic borrowing Deep neural networks Historical control Survival analysis

Bayesian Time-Drift and Time-Decay models in Platform Trial

9:45 AM - 10:30 AM

Co-authors: Yifan Yi, Ruitao Lin (University of Texas, MD Anderson Cancer Center)

Adaptive platform trials Bayesian time-machine models Non-concurrent borrowing Power likelihood Time-Decay Propensity score weighting

BEACON: An Adaptive Bayesian Early-Phase Oncology Trial Design Integrating Dose Optimization and Proof-of-Concept Across Survival and Binary Endpoints

9:45 AM - 10:30 AM

Co-authors: Yike Tang, Feng Tian (Bristol Myers Squibb), Xiaochen Zhu (BMS), Guotao Chu (BMS), Liangang Liu, Hsin-Ju Hsieh (Bristol Myers Squibb), Shu-Pang Huang (NCSU)

Dose optimization Bayesian design Proof-of-concept Survival endpoints Information borrowing

Beyond a Single Intercurrent Event: Reason-Specific Handling of Treatment Discontinuation in Crossover Trials

9:45 AM - 10:30 AM

Co-authors: Yubo Tan, Yutong Lu (AstraZeneca Canada Inc.), David Petullo (AstraZeneca)

Estimand Intercurrent event Crossover trial Principal Stratum Strategy Treatment Policy Strategy Treatment Discontinuation

DCTwin: Efficient, Robust, and Privacy-Preserving Bayesian Transfer Learning for Adaptive Information Borrowing from External Data

9:45 AM - 10:30 AM

Co-authors: Xiaohan Chi, Ying Yuan (University of Texas MD Anderson Cancer Center), Ruitao Lin (University of Texas, MD Anderson Cancer Center)

Randomized controlled trials External data Information borrowing AI/ML

Demonstrating Substantial Evidence of Effectiveness Within a Single Pivotal Trial: A Statistical Approach

9:45 AM - 10:30 AM

Co-authors: Jesse Helman (AstraZeneca), Marina Hernandez (Johns Hopkins University)

Substantial Evidence of Effectiveness Evidence generation Single trial Pivotal Sample Size FDA opinion

Enabling Trustworthy Decision-Making with Shared Data: Lessons from Rare Disease for Oncology Development

9:45 AM - 10:30 AM

Co-authors: Yefei Zhang (Takeda pharmaceuticals)

Data sharing Decision making Evidence integration Oncology clinical trials External control arms

Estimand Considerations in Real-World Evidence: Intercurrent event handling under informative treatment discontinuation

9:45 AM - 10:30 AM

Co-authors: Griffith Bell, Milena Gianfrancesco (Pfizer, Inc)

estimands rwe real-world evidence intercurrent events

KM-GPT: An Automated Pipeline for Reconstructing Individual Patient Data from Kaplan-Meier Plots

9:45 AM - 10:30 AM

Co-authors: Yao Zhao, Haoyue Sun (Johns Hopkins University), Yantian Ding (DataMind), Yanxun Xu (Johns Hopkins University)

Automated Pipeline Evidence-Based Decision-Making Individual Patient Data Kaplan–Meier Plot Multi-Modality Language Model

Machine Learning–Generated Digital Twins as External Controls

9:45 AM - 10:30 AM

Co-authors: Run Zhuang (Unlearn.AI), Aaron Smith (Unlearn.AI), Daniele Bertolini (Unlearn.AI), Franklin Fuller (Unlearn.AI), Jonathan Walsh (Unlearn.AI)

External Control Digital Twins Hybrid Trials

Modernizing Clinical Regulatory Submissions: The R Consortium Submission Working Group's 2026 Roadmap for R-Based Submissions and Workflows

9:45 AM - 10:30 AM

Co-authors: Ning Leng (Abbvie), Eric Nantz (Eli Lilly and Company)

submission AI open source

Multiple Imputation for Small, Extremely High Efficacy Clinical Trials with Binary Endpoints

9:45 AM - 10:30 AM

Co-authors: Yaoyuan Vincent Tan (Vertex Pharmaceuticals), Chenkun Wang (Vertex Pharmaceuticals Inc), Xu Gang (Vertex Pharmaceuticals)

binary endpoints CIT07 extremely high success rate multiple imputation small sample size proportion of success

Multiple Testing Procedures for Identifying the Best Intervention in Multi-Arm Trials with Ordinal Outcomes

9:45 AM - 10:30 AM

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

Multi-arm trials Multiple testing Best intervention selection Ordinal outcomes

Opposing Conclusions in Indirect Comparisons Arising from Target Population Differences in MAIC and STC

9:45 AM - 10:30 AM

Co-authors: Zilin Wang (University of Arizona), Lifeng Lin, Haitao Chu (Pfizer)

Indirect treatment comparison Matching-adjusted indirect comparison (MAIC)Simulated treatment comparison (STC)Target population Health technology assessment (HTA)

Optimizing Experimental Design for Limit of Detection (LoD) Establishment

9:45 AM - 10:30 AM

Co-authors: Brian Hart (Natera), Kehao Zhu (Natera), Jessica Larson (Natera, Inc)

ctDNA Limit of Detection Design of Experiments

Practical Application of Modified Reference-based Multiple Imputation for Time-to-Event Endpoint with Informative Censoring

9:45 AM - 10:30 AM

Co-authors: Amy Shi (AstraZeneca), Bonifride Tuyishimire (Astrazeneca)

Multiple Imputation Missing-not-at-random Intercurrent Events Sensitivity Analysis Informative Censoring Estimands

Recurrence: An Analysis of Adverse Events Whose Time Has Come in the Evaluation of Patient Safety in Clinical Trials

9:45 AM - 10:30 AM

Co-authors: Richard Zink (JMP Statistical Discovery LLC)

Adverse events Aggregate safety assessments Data visualization MedDRA Medical queries Scientific evaluation of safety data

Recursive Cluster Elimination for Enriching Candidate Genes Contributing to Voluntary Alcohol Consumption in Adolescent Mice

9:45 AM - 10:30 AM

Co-authors: IVANA Albert, Yongqi Chen (UC Santa Cruz)

Recursive Cluster Elimination Gene Selection Alcohol Use Disorder

SIMONE - An Integrated Bayesian Simulation Framework for Clinical Trial Designs with AI-Orchestrated Workflow

9:45 AM - 10:30 AM

Co-authors: Bingying Dai (Regeneron), Nusrat Rabbee (Regeneron Pharmaceuticals, Inc), Weibin Zhong (Regeneron), Chenguang Wang (Regeneron Pharmaceuticals, Inc.)

Bayesian clinical trial design simulation framework AI-Orchestrated Prior construction AI skill

Study Design and Statistical Considerations for Clinical Validation of Digital Pathology Devices

9:45 AM - 10:30 AM

Co-authors: Ji Hye Park (FDA/CDRH), Ge Feng (FDA)

Digital Pathology Diagnostics Medical device Clinical validation

Study-Specific Adaptive Mixture Priors for Heterogeneous Historical Data in Clinical Trials

9:45 AM - 10:30 AM

Co-authors: Indrajit Ghosh (Eli Lilly & Company), Ayon Mukherjee (Eli Lilly)

Dynamic Borrowing Adaptive Control Augmentation External Information Borrowing Mixture Priors

Poster Session II

30 Presentations