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

Share

COinS
 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.