Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical Trials.
Journal:
Drug safety
Published Date:
Jul 14, 2021
Abstract
INTRODUCTION: Safety underreporting is a recurrent issue in clinical trials that can impact patient safety and data integrity. Clinical quality assurance (QA) practices used to detect underreporting rely on on-site audits; however, adverse events (AEs) underreporting remains a recurrent issue. In a recent project, we developed a predictive model that enables oversight of AE reporting for clinical quality program leads (QPLs). However, there were limitations to using solely a machine learning model.