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

ABSTRACT:

Background/aims

Regulatory guidelines recommend that sponsors develop a risk-based approach to monitoring clinical trials. However, there is a lack of evidence to guide the effective implementation of monitoring activities encompassed in this approach. The aim of this study was to assess the efficiency and impact of the risk-based monitoring approach used for a multicentre randomised controlled trial comparing treatments in paediatric patients undergoing cardiac bypass surgery.

Methods

This is a secondary analysis of data from a randomised controlled trial that implemented targeted source data verification as part of the risk-based monitoring approach. Monitoring duration and source to database error rates were calculated across the monitored trial dataset. The monitored and

SUBMITTER: Le Marsney R 

PROVIDER: S-EPMC11304638 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature