Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials. (November 2015)

• Record Type: Journal Article
• Authors: Ma, Haijun; Ke, Chunlei; Jiang, Qi; Snapinn, Steven
• Is Part Of: Therapeutic innovation & regulatory science. Volume 49:Number 6(2015:Nov.)
• Page Start: 957
• Page End: 965
• Publication Date: 2015-11
• Subjects: adverse event -- clinical trial -- imbalance -- safety signal -- adverse drug reaction; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479015587363
• Languages: English
• ISSNs: 2168-4790

Abstract

Adverse events (AEs) data compose the main body of safety data in clinical trials. Medically important imbalances of AEs in large double-blind randomized controlled trials (RCTs) are signals of potential adverse drug reactions. They will be further evaluated for causality and shape the initial label that gives users necessary information on the safe use of the drug. However, causality assessment in premarketing RCTs can be challenging. This article highlights key aspects that need attention and statistical analysis approaches that could be helpful for screening and evaluation of signals generated from imbalances of AEs in moderate or large RCTs.