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Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent

L M Perrem1, S Gosling2, I Ravikumar2

  • 1Coombe Women and Infants University Hospital, Dublin 8, Ireland.

Acta Paediatrica (Oslo, Norway : 1992)
|September 18, 2016
PubMed

Insights

Most neonatal randomized controlled trials (RCTs) report data monitoring committees (DMCs) and interim analyses. However, clear documentation of stopping rules and early trial terminations in these infant studies needs improvement.

Area of Science:

  • Neonatal research
  • Clinical trial methodology
  • Pediatric medicine

Background:

  • Data Monitoring Committees (DMCs) play a crucial role in ensuring patient safety during clinical trials.
  • Neonatal randomized controlled trials (RCTs) involve vulnerable populations, necessitating rigorous safety monitoring.
  • Reporting standards for safety measures in pediatric trials can vary.

Purpose of the Study:

  • To assess the reported utilization of DMCs in neonatal RCTs.
  • To determine the frequency of interim analyses and prespecified stopping rules in neonatal trials.
  • To evaluate the incidence of early trial termination in studies involving newborn infants.

Main Methods:

  • A systematic review of neonatal RCTs published between 2003 and 2013 was conducted.
  • Trials were identified from four high-impact general medical journals.
  • Key parameters assessed included DMC involvement, interim analysis, stopping rules, and early termination.

Main Results:

  • Seventy neonatal RCTs were analyzed.
  • Data monitoring committee involvement was reported in 61.4% of trials.
  • Interim analysis was mentioned in 51.4%, stopping rules in 21.4%, and early termination in 10% of trials.
  • The New England Journal of Medicine (NEJM) showed higher reporting rates for these parameters.

Conclusions:

  • While DMC involvement and interim analysis are frequently reported in neonatal RCTs, improvements in documenting stopping rules and early terminations are needed.
  • Enhanced reporting of safety-related aspects is crucial for neonatal clinical trials.
  • Standardized reporting of safety monitoring practices will improve the transparency and reliability of neonatal research.
Abstract

Keywords:
Clinical trialsDMCsData monitoring committeesInterim analysisNeonatalRCTsRandomised controlled trialsStopping rules

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