Open AccessInterim data monitoring in cluster randomised trials: Practical issues and a case study
Author(s) -
Karla Hemming,
James Martín,
Ioannis Gallos,
Arri Coomarasamy,
Lee Middleton
Publication year - 2021
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/17407745211024751
Subject(s) - interim , cluster randomised controlled trial , sample size determination , interim analysis , clinical trial , cluster (spacecraft) , medicine , data collection , computer science , psychological intervention , data mining , statistics , mathematics , archaeology , pathology , psychiatry , history , programming language
There is an abundance of guidance for the interim monitoring of individually randomised trials. While methodological literature exists on how to extend these methods to cluster randomised trials, there is little guidance on practical implementation. Cluster trials have many features which make their monitoring needs different. We outline the methodological and practical challenges of interim monitoring of cluster trials; and apply these considerations to a case study.