Faculty, Staff and Student Publications
Language
English
Publication Date
3-1-2026
Journal
Research Synthesis Methods
DOI
10.1017/rsm.2025.10052
PMID
41635945v
PMCID
PMC12873611
PubMedCentral® Posted Date
11-24-2025
PubMedCentral® Full Text Version
Post-print
Abstract
Accurate assessment of adverse event (AE) incidence is critical in clinical research for drug safety. While meta-analysis serves as an essential tool to comprehensively synthesize the evidence across multiple studies, incomplete AE reporting in clinical trials remains a persistent challenge. In particular, AEs occurring below study-specific reporting thresholds are often omitted from publications, leading to left-censored data. Failure to account for these censored AE counts can result in biased AE incidence estimates. We present an R Shiny application that implements a Bayesian meta-analysis model specifically designed to incorporate censored AE data into the estimation process. This interactive tool provides a user-friendly interface for researchers to conduct AE meta-analyses and estimate the AE incidence probability using an unbiased approach. It also enables direct comparisons between models that either incorporate or ignore censoring, highlighting the biases introduced by conventional approaches. This tutorial demonstrates the Shiny application’s functionality through an illustrative example on meta-analysis of PD-1/PD-L1 inhibitor safety and highlights the importance of this tool in improving AE risk assessment. Ultimately, the new Shiny app facilitates more accurate and transparent drug safety evaluations. The Shiny-MAGEC app is available at: https://zihanzhou98.shinyapps.io/Shiny-MAGEC/
Keywords
Bayes Theorem, Humans, Meta-Analysis as Topic, Drug-Related Side Effects and Adverse Reactions, Software, Risk Assessment, Incidence, Probability, Models, Statistical, Immune Checkpoint Inhibitors, Research Design, Algorithms, Bayesian inference, drug safety, incomplete reporting, MAGEC, meta-analysis
Published Open-Access
yes
Recommended Citation
Zhou, Zihan; Tian, Zizhong; Peterson, Christine; et al., "Shiny-Magec: A Bayesian R Shiny Application for Meta-Analysis of Censored Adverse Events" (2026). Faculty, Staff and Student Publications. 6417.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/6417
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Bioinformatics Commons, Biomedical Informatics Commons, Genetic Phenomena Commons, Medical Genetics Commons, Oncology Commons