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6 papers

stat.ME2026

Empirical Simulation of Survival and Mixed-Type Data for Clinical Trial Design

Yao Chen, Jiren Sun, Yuxin Ding +2

Simulating realistic time-to-event data is essential for planning and evaluating complex clinical trial designs. Conventional approaches often sample event times from parametric fa…

stat.ME2026

Optimizing Efficiency and Convergence in MMRM: Practical Considerations for Longitudinal Data Analysis

Dylan Clarke, Jeremiah Jones, Yongming Qu

The paper studies how to improve convergence and efficiency of mixed models for repeated measures (MMRM) in longitudinal clinical trial data, recommending specific covariance struc…

stat.ME2026

Estimating treatment effects with competing intercurrent events in randomized controlled trials

Sizhu Lu, Yanyao Yi, Yongming Qu +3

The analysis of randomized controlled trials is often complicated by intercurrent events (IEs) -- events that occur after treatment initiation and affect either the interpretation…

stat.ME2026

An Empirical Method for Analyzing Count Data

Jiren Sun, Linda Amoafo, Yongming Qu

Count endpoints are common in clinical trials, particularly for recurrent events such as hypoglycemia. When interest centers on comparing overall event rates between treatment grou…

stat.ME2024

Direct Estimation for Commonly Used Pattern-Mixture Models in Clinical Trials

Jitong Lou, Mallikarjuna Rettiganti, Yongming Qu

Pattern-mixture models have received increasing attention as they are commonly used to assess treatment effects in primary or sensitivity analyses for clinical trials with nonignor…

stat.AP2024

Retrieved dropout imputation considering administrative study withdrawal

Rong Liu, Yongming Qu

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9 (R1) Addendum provides a framework for defining estimands in clinic…