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Systematic review of safety in paediatric drug trials published in 2007

Khairun Nain Bin Nor Aripin1, Imti Choonara, Helen M Sammons

  • 1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK. khairun@usim.edu.my

European Journal of Clinical Pharmacology
|August 23, 2011
PubMed

Insights

Children in drug trials face moderate to severe adverse drug reactions (ADRs). Establishing data safety monitoring boards (DSMBs) is crucial for ensuring child participant safety in clinical research.

Area of Science:

  • Pediatric Pharmacology
  • Clinical Trial Safety
  • Drug Development

Background:

  • Increasing participation of children in drug trials necessitates robust safety measures.
  • Children in clinical trials are susceptible to moderate and severe adverse drug reactions (ADRs).
  • A significant gap exists in the implementation of data safety monitoring boards (DSMBs) for paediatric drug trials.

Purpose of the Study:

  • To analyze the incidence and severity of ADRs in paediatric drug randomized controlled trials (RCTs).
  • To assess the presence and impact of independent data safety monitoring boards (DSMBs) in these trials.

Main Methods:

  • Systematic review of paediatric drug RCTs published in 2007.
  • Classification and severity assessment of reported adverse events (AEs) to identify ADRs.
  • Examination of trial reports for the presence of independent DSMBs.

Main Results:

  • Over half of the analyzed RCTs (305) reported ADRs, with 66 (11%) being severe and 79 (14%) moderate.
  • Serious adverse events, including mortality, were reported in 36% of trials.
  • Only 12% of RCTs reported having a DSMB, though these boards did intervene to terminate trials or alter protocols.

Conclusions:

  • Paediatric participants in drug RCTs experience a substantial number and variety of ADRs.
  • The implementation of DSMBs is essential for safeguarding children in clinical drug trials.
  • DSMBs play a vital role in monitoring trial safety and can necessitate protocol changes or early termination.
Abstract

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