Systematic review of safety in paediatric drug trials published in 2007 View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2012-02

AUTHORS

Khairun Nain Bin Nor Aripin, Imti Choonara, Helen M. Sammons

ABSTRACT

BACKGROUND: There is now greater involvement of children in drug trials to ensure that paediatric medicines are supported by sound scientific evidence. The safety of the participating children is of paramount importance. Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial. METHODS: Safety data from a systematic review of paediatric drug randomised controlled trials (RCTs) published in 2007 were analysed. All reported adverse events (AEs) were classified and assessed to determine whether an ADR had been experienced. ADRs were then categorised according to severity. Each trial report was examined as to whether an independent DSMB was in place. RESULTS: Of the 582 paediatric drug RCTs analysed, 210 (36%) reported that a serious AE had occurred, and in 15% mortality was reported. ADRs were detected in more than half of the RCTs (305); 66 (11%) were severe, and 79 (14%) were moderate. Severe ADRs involved a wide range of organ systems and were frequently associated with cytotoxic drugs, antiparasitics, anticonvulsants and psychotropic drugs. Two RCTs reported significantly higher mortality rates in the treatment group. Only 69 (12%) of the RCTs stated there was a DSMB. DSMBs terminated five RCTs and changed the protocol in one. CONCLUSIONS: Children participating in drug RCTs experience a significant amount and a wide range of ADRs. DSMBs are needed to ensure the safety of paediatric participants in clinical drug trials. More... »

PAGES

189-194

References to SciGraph publications

  • 2007-06. Inhaled nitric oxide in infants >1500 g and <34 weeks gestation with severe respiratory failure in JOURNAL OF PERINATOLOGY
  • 2005-04. Clinical trials of medication in children, 1996–2002 in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • 2008-01. The conscientious judgement of a DSMB – statistical stopping rules re-examined in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • 2008-02. Paediatric clinical pharmacology—at the beginning of a new era in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00228-011-1112-6

    DOI

    http://dx.doi.org/10.1007/s00228-011-1112-6

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1042208087

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/21858432


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