6 papers
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…
Capturing Cumulative Disease Burden in Chronic Kidney Disease Outcome Trials: Area Under the Curve and Restricted Mean Time in Favor of Treatment Beyond Conventional Time-to-First Analysis
Jiren Sun, Tuo Wang, Yu Du
Chronic kidney disease (CKD) affects millions worldwide and progresses irreversibly through stages culminating in end-stage renal disease (ESRD) and death. Outcome trials in CKD tr…
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…
Inverse Probability Weighting for Recurrent Event Models
Jiren Sun, Tobias Mutze, Richard Cook +1
Recurrent events are common and important clinical trial endpoints in many disease areas, e.g., cardiovascular hospitalizations in heart failure, relapses in multiple sclerosis, or…
Improve the Precision of Area Under the Curve Estimation for Recurrent Events Through Covariate Adjustment
Jiren Sun, Tuo Wang, Yanyao Yi +3
The area under the curve (AUC) of the mean cumulative function (MCF) has recently been introduced as a novel estimand for evaluating treatment effects in recurrent event settings,…
On the Proportional Principal Stratum Hazards Model
Jiren Sun, Thomas D. Cook
In clinical trials involving both mortality and morbidity, an active treatment can influence the observed risk of the first non-fatal event either directly, through its effect on t…