activity
20232026
most citedA Causal Roadmap for Generating High-Quality Real-World Evidence

10 citations · 10 across the 7 of their papers we have counts for

collaborators

7 papers

stat.ME2026

From Cumulative Weights to Marginal Density Ratios: Per-Protocol Estimation in Sequential Target Trial Emulation

Zern Ke, Mingshi Cui, Feng Dai +3

Sequential target trial emulation evaluates eligibility at multiple baseline times to emulate a sequence of randomized trials using observational data. Estimating per-protocol effe…

stat.ME2026

Towards Best Practices for Covariate Adjustment in Regulatory Trials: From Fixed to Data-Adaptive Approaches

Laura B. Balzer, Lei Nie, Issa J. Dahabreh +15

While randomization justifies the use of unadjusted effect estimators in randomized trials, there is growing interest in covariate adjustment to improve precision. Adjusting for ba…

stat.ME2026

Mitigating the Winner's Curse While Controlling Multiplicity: e-Process Methods for Anytime-Valid Inference in Dose-Ranging Trials

Victor K. de la Pena, Fangyuan Lin, Demissie Alemayehu +1

Phase II dose-ranging trials often report the largest observed dose-control effect while inspecting accumulating data repeatedly. This creates two coupled distortions: selection op…

stat.AP2026

Advancing Evidence Generation in Biomedical Research Using Natural Hermite and Propensity Score Indices: Applications to External Control Arms

Javier Cabrera, Berhanu Alemayehu, Demissie Alemayehu +1

When it is not feasible to conduct randomized controlled trials (RCTs), the use of external control arms based on real-world data (RWD) may be a viable option. However, challenges…

math.PR2025

Sharp Decoupling Inequalities for the Variances and Second Moments of Sums of Dependent Random Variables

Victor H. de la Pena, Heyuan Yao, Demissie Alemayehu

Both complete decoupling and tangent decoupling are classical tools aiming to compare two random processes where one has a weaker dependence structure. We give a new proof for the…

stat.ME2023★ 10 cited

A Causal Roadmap for Generating High-Quality Real-World Evidence

Lauren E Dang, Susan Gruber, Hana Lee +23

Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks…

math.ST2023

Prediction and estimation of random variables with infinite mean or variance

Victor de la Pena, Henryk Gzyl, Silvia Mayoral +2

In this paper we propose an optimal predictor of a random variable that has either an infinite mean or an infinite variance. The method consists of transforming the random variable…