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Related papers: Visualizing adverse events in clinical trials usin…

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Objectives: With accurate estimates of expected safety results, clinical trials could be better designed and monitored. We evaluated methods for predicting serious adverse event (SAE) results in clinical trials using information only from…

Computation and Language · Computer Science 2025-08-12 Qixuan Hu , Xumou Zhang , Jinman Kim , Florence Bourgeois , Adam G. Dunn

Analyzing and effectively communicating the efficacy and toxicity of treatment is the basis of risk benefit analysis (RBA). More efficient and objective tools are needed. We apply Chauhan Weighted Trajectory Analysis (CWTA) to perform RBA…

Methodology · Statistics 2024-09-24 Utkarsh Chauhan , Daylen Mackey , John R Mackey

This paper proposes a new method for analysis of adverse event data in clinical trials. The method is illustrated by application to data on 4 phase III clinical trials, two on breast cancer and two on diabetes mellitus.

Applications · Statistics 2018-06-04 Sharayu Paranjpe , Anil Gore

Medical image analysis is central to drug discovery and preclinical evaluation, where scalable, objective readouts can accelerate decision-making. We address classification of paclitaxel (Taxol) exposure from phase-contrast microscopy of C6…

Computer Vision and Pattern Recognition · Computer Science 2025-11-06 Sean Fletcher , Gabby Scott , Douglas Currie , Xin Zhang , Yuqi Song , Bruce MacLeod

Learning causal effects from observational data greatly benefits a variety of domains such as health care, education and sociology. For instance, one could estimate the impact of a new drug on specific individuals to assist the clinic plan…

Machine Learning · Computer Science 2021-05-19 Xin Du , Lei Sun , Wouter Duivesteijn , Alexander Nikolaev , Mykola Pechenizkiy

Clinical trials are the basis of Evidence-Based Medicine. Trial results are reviewed by experts and consensus panels for producing meta-analyses and clinical practice guidelines. However, reviewing these results is a long and tedious task,…

Computers and Society · Computer Science 2021-04-21 Jean-Baptiste Lamy

Adverse drug interactions are a critical concern in pharmacovigilance, as both clinical trials and spontaneous reporting systems often lack the breadth to detect complex drug interactions. This study introduces a computational framework for…

Applications · Statistics 2025-04-02 Jules Bangard , Einar Holsbø , Kristian Svendsen , Vittorio Perduca , Etienne Birmelé

The SAVVY project aims to improve the analyses of adverse event (AE) data in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs). Although statistical…

Drug combination trials are increasingly common nowadays in clinical research. However, very few methods have been developed to consider toxicity attributions in the dose escalation process. We are motivated by a trial in which the…

Methodology · Statistics 2018-08-23 Jose L. Jimenez , Mourad Tighiouart , Mauro Gasparini

Cardiovascular outcome trials commonly face competing risks when non-CV death prevents observation of major adverse cardiovascular events (MACE). While Cox proportional hazards models treat competing events as independent censoring,…

Methodology · Statistics 2026-02-19 Tuo Wang , Yu Du

Motivation: Visualization of data is a crucial step to understanding and deriving hypotheses from clinical data. However, for clinicians, visualization often comes with great effort due to the lack of technical knowledge about data handling…

Quantitative Methods · Quantitative Biology 2023-06-14 Philipp Wegner , Sebastian Schaaf , Mischa Uebachs , Marcus Grobe-Einsler , Thomas Klockgether , Juliane Fluck , Jennifer Faber

Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete…

Estimating causal effects from observational data is inherently challenging due to the lack of observable counterfactual outcomes and even the presence of unmeasured confounding. Traditional methods often rely on restrictive, untestable…

Methodology · Statistics 2025-04-07 Li Chen , Xiaotong Shen , Wei Pan

Background and Objective: In meta-analysis based on continuous outcome, estimated means and corresponding standard deviations from the selected studies are key inputs to obtain a pooled estimate of the mean and its confidence interval. We…

Computation · Statistics 2020-04-07 Roopesh Reddy Sadashiva Reddy , Isildinha M. Reis , Deukwoo Kwon

Causal decomposition analysis aims to assess the effect of modifying risk factors on reducing social disparities in outcomes. Recently, this analysis has incorporated individual characteristics when modifying risk factors by utilizing…

Machine Learning · Statistics 2025-09-16 Soojin Park , Suyeon Kang , Chioun Lee

In clinical trials, an experimental treatment is sometimes added on to a standard of care or control therapy in multiple treatment phases (e.g., concomitant and maintenance phases) to improve patient outcomes. When the new regimen provides…

Methodology · Statistics 2020-11-19 Sudipta Bhattacharya , Jyotirmoy Dey

NOTE: This preprint has a flawed theoretical formulation. Please avoid it and refer to the ICLR22 publication https://openreview.net/forum?id=q7n2RngwOM. Also, arXiv:2109.15062 contains some new ideas on unobserved Confounding. As an…

Machine Learning · Statistics 2022-04-22 Pengzhou Wu , Kenji Fukumizu

In precision medicine, deriving the individualized treatment rule (ITR) is crucial for recommending the optimal treatment based on patients' baseline covariates. The covariate-specific treatment effect (CSTE) curve presents a graphical…

Computation · Statistics 2025-08-22 Yi Zhou , Yuhao Deng , Yu-Shi Tian , Peng Wu , Wenjie Hu , Haoxiang Wang , Ewout Steyerberg , Xiao-Hua Zhou

We introduce a Bayesian nonparametric inference approach for aggregate adverse event (AE) monitoring across studies. The proposed model seamlessly integrates external data from historical trials to define a relevant background rate and…

Methodology · Statistics 2025-09-10 Shijie Yuan , Kevin Roberts , Noirrit Kiran Chandra , Yuan Ji , Peter Müller

Anonymizing microdata requires balancing the reduction of disclosure risk with the preservation of data utility. Traditional evaluations often rely on single measures or two-dimensional risk-utility (R-U) maps, but real-world assessments…

Applications · Statistics 2026-04-10 Oscar Thees , Roman Müller , Matthias Templ