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

Renate Le Marsney1, Kerry Johnson1,2, Jenipher Chumbes Flores3

  • 1Children's Intensive Care Research Program, Child Health Research Centre, The University of Queensland, South Brisbane, QLD, Australia.

Clinical Trials (London, England)
|February 29, 2024
PubMed

Insights

Targeted source data verification in pediatric cardiac surgery trials did not impact outcomes despite significant time investment. This suggests reduced emphasis on source data verification may be appropriate in certain clinical trial monitoring contexts.

Area of Science:

  • Clinical Trials
  • Cardiovascular Surgery
  • Pediatric Medicine

Background:

  • Regulatory guidelines advocate for risk-based monitoring in clinical trials.
  • Evidence for effective implementation of risk-based monitoring activities is limited.
  • This study addresses the efficiency and impact of risk-based monitoring in a pediatric cardiac surgery trial.

Purpose of the Study:

  • To assess the efficiency and impact of a risk-based monitoring approach.
  • Evaluate targeted source data verification within a multicentre randomized controlled trial.
  • Provide evidence for optimizing clinical trial monitoring strategies.

Main Methods:

  • Secondary analysis of a multicentre randomized controlled trial.
  • Implemented targeted source data verification as part of risk-based monitoring.
  • Calculated monitoring duration and source-to-database error rates.
  • Compared monitored, unmonitored, and simulated trial datasets.

Main Results:

  • 106,749 data points from 1,282 participants were verified.
  • Total monitoring time was 365 hours (median 10 minutes/participant).
  • Overall source-to-database error rate was 3.1%, with minimal impact on trial outcomes.
  • Simulated datasets showed minimal impact of reduced verification or cohort size on outcomes.

Conclusions:

  • Targeted source data verification, despite time costs, did not influence study outcomes.
  • This evaluation supports a reduced emphasis on source data verification as a primary monitoring activity in specific contexts.
  • Contributes to the evidence base for cost-effective clinical trial monitoring.
Abstract

Keywords:
Clinical trialdata qualitymonitoringquality assurancerisk-based monitoringsource data verificationtargeted monitoring

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