Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial.

Renate Le MarsneyKerry JohnsonJenipher Chumbes FloresShelley CoetzerJennifer DarvasCarmel DelzoppoArielle JollyKate MastersonClaire SherringHannah ThomsonEndrias ErgetuPatricia GilholmKristen S Gibbons

Published in: Clinical trials (London, England) (2024)

Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity.

Keyphrases

electronic health record
study protocol
big data
clinical trial
data analysis
machine learning
metabolic syndrome
deep learning
weight loss
open label
insulin resistance
breast cancer risk