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Context: Software Engineering (SE) experiments suffer from threats to validity that may impact their results. Replication allows researchers building on top of previous experiments' weaknesses and increasing the reliability of the findings.…

Software Engineering · Computer Science 2020-04-14 Adrian Santos , Sira Vegas , Fernando Uyaguari , Oscar Dieste , Burak Turhan , Natalia Juristo

Machine learning (ML) based approaches are increasingly being used in a number of applications with societal impact. Training ML models often require vast amounts of labeled data, and crowdsourcing is a dominant paradigm for obtaining…

Machine Learning · Computer Science 2023-04-26 Simone Lazier , Saravanan Thirumuruganathan , Hadis Anahideh

Studies in circadian biology often use trigonometric regression to model phenomena over time. Ideally, protocols in these studies would collect samples at evenly distributed and equally spaced time points over a 24 hour period. This sample…

Methodology · Statistics 2024-03-22 Michael Gorczyca , Justice Sefas

Randomized controlled trials (RCTs) have been the cornerstone of clinical evidence; however, their cost, duration, and restrictive eligibility criteria limit power and external validity. Studies using real-world data (RWD), historically…

Methodology · Statistics 2025-11-26 Shu Yang , Margaret Gamalo , Haoda Fu

Linear regression is arguably the most fundamental statistical model; however, the validity of its use in randomized clinical trials, despite being common practice, has never been crystal clear, particularly when stratified or…

Methodology · Statistics 2023-02-14 Wei Ma , Fuyi Tu , Hanzhong Liu

Quasi-experimental research designs, such as regression discontinuity and interrupted time series, allow for causal inference in the absence of a randomized controlled trial, at the cost of additional assumptions. In this paper, we provide…

Methodology · Statistics 2021-12-15 Max Hinne , David Leeftink , Marcel A. J. van Gerven , Luca Ambrogioni

The primary goal of dose allocation in phase I trials is to minimize patient exposure to subtherapeutic or excessively toxic doses, while accurately recommending a phase II dose that is as close as possible to the maximum tolerated dose…

Methodology · Statistics 2025-03-21 Jiapeng Xu , Dehua Bi , Shenghua Kelly Fan , Bee Leng Lee , Ying Lu

Outcome-dependent sampling designs are common in many different scientific fields including epidemiology, ecology, and economics. As with all observational studies, such designs often suffer from unmeasured confounding, which generally…

Methodology · Statistics 2020-10-13 Erin E. Gabriel , Michael C. Sachs , Arvid Sjölander

To ensure reliable causal conclusions from observational (i.e., non-randomized) studies, researchers routinely conduct sensitivity analysis to assess robustness to hidden bias due to unmeasured confounding. In matched observational studies…

Methodology · Statistics 2025-11-11 Siyu Heng , Elaine K. Chiu , Hyunseung Kang

Researchers often turn to block randomization to increase the precision of their inference or due to practical considerations, such as in multisite trials. However, if the number of treatments under consideration is large it might not be…

Methodology · Statistics 2025-08-26 Taehyeon Koo , Nicole E. Pashley

Randomized trials are considered the gold standard for making informed decisions in medicine, yet they often lack generalizability to the patient populations in clinical practice. Observational studies, on the other hand, cover a broader…

Methodology · Statistics 2026-04-14 Piersilvio De Bartolomeis , Javier Abad , Konstantin Donhauser , Fanny Yang

The difference-in-differences (DiD) design is a quasi-experimental method for estimating treatment effects. In staggered DiD with multiple treatment groups and periods, estimation based on the two-way fixed effects model yields negative…

Methodology · Statistics 2026-03-05 Yuhao Deng , Le Kang

Statistical inference of heterogeneous treatment effects (HTEs) across predefined subgroups is challenging when units interact because treatment effects may vary by pre-treatment variables, post-treatment exposure variables (that measure…

Econometrics · Economics 2024-10-02 Julius Owusu

Regression discontinuity designs have been widely used in observational studies to estimate causal effects of an intervention or treatment at a cutoff point. We propose a generalization of regression discontinuity designs to handle complex…

Methodology · Statistics 2025-06-24 Daisuke Kurisu , Yidong Zhou , Taisuke Otsu , Hans-Georg Müller

Introduction: Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the Causal Roadmap, we specify three designs to evaluate the difference in risk of major adverse…

In Regression Discontinuity (RD) design, self-selection leads to different distributions of covariates on two sides of the policy intervention, which essentially violates the continuity of potential outcome assumption. The standard RD…

Methodology · Statistics 2019-11-22 Sida Peng , Yang Ning

Post-Traumatic Stress Disorder (PTSD) remains underdiagnosed in clinical settings, presenting opportunities for automated detection to identify patients. This study evaluates natural language processing approaches for detecting PTSD from…

Computation and Language · Computer Science 2026-01-08 Feng Chen , Dror Ben-Zeev , Gillian Sparks , Arya Kadakia , Trevor Cohen

We consider the problem of estimating the average treatment effect (ATE) when both randomized control trial (RCT) data and external real-world data (RWD) are available. We decompose the ATE estimand as the difference between a pooled-ATE…

Methodology · Statistics 2025-01-22 Mark van der Laan , Sky Qiu , Jens Magelund Tarp , Lars van der Laan

Heterogeneous treatment effects can be very important in the analysis of randomized clinical trials. Heightened risks or enhanced benefits may exist for particular subsets of study subjects. When the heterogeneous treatment effects are…

Methodology · Statistics 2025-07-25 Richard A. Berk , Matthew Olson , Andreas Buja , Aurelie Ouss

Estimating heterogeneous treatment effects is central to data-driven decision-making, yet industrial applications often face a fundamental tension between limited randomized controlled trial (RCT) budgets and abundant but biased…