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Safety in paediatric clinical trials--a 7-year review

H M Sammons1, C Gray, H Hudson

  • 1Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. Helen.sammons@nottingham.ac.uk

Acta Paediatrica (Oslo, Norway : 1992)
|March 1, 2008
PubMed

Insights

This study reviewed pediatric clinical trials, finding that 11% had moderate or severe adverse drug reactions (ADRs). Safety monitoring committees (SMCs) are crucial for all pediatric clinical trials to ensure patient safety.

Area of Science:

  • Pediatric Clinical Trials
  • Drug Safety Monitoring
  • Adverse Drug Reactions

Background:

  • The safety of pediatric clinical trials has been understudied.
  • Understanding safety monitoring and adverse drug reactions (ADRs) in children is critical.

Purpose of the Study:

  • To investigate safety monitoring practices in pediatric clinical trials.
  • To determine the incidence and severity of adverse drug reactions (ADRs) in children.

Main Methods:

  • Literature review of Medline Database for therapeutic clinical trials in children (1996-2002).
  • Analysis of papers to identify safety monitoring and adverse events (AEs) or ADRs.

Main Results:

  • 739 trials reviewed; only 2% had safety monitoring committees (SMCs).
  • 71% reported AEs, 20% reported serious AEs; 36.5% reported ADRs, with 11% moderate/severe.
  • 6 trials terminated due to toxicity (all had SMCs); 11% of trials reported deaths.

Conclusions:

  • Approximately 11% of pediatric clinical trials experience moderate to severe ADRs.
  • Implementation of safety monitoring committees (SMCs) is recommended for all pediatric clinical trials.
Abstract

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