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Systematic review of safety in paediatric drug trials published in 2007

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dc.contributor.authorAripin, KNBNen_US
dc.contributor.authorChoonara, Ien_US
dc.contributor.authorSammons, HMen_US
dc.date.accessioned2024-05-29T03:25:08Z
dc.date.available2024-05-29T03:25:08Z
dc.date.issued2012
dc.description.abstractThere 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. 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. 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. 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.
dc.identifier.doi10.1007/s00228-011-1112-6
dc.identifier.epage194
dc.identifier.issn0031-6970
dc.identifier.issue2
dc.identifier.scopusWOS:000299093900011
dc.identifier.spage189
dc.identifier.urihttps://oarep.usim.edu.my/handle/123456789/11875
dc.identifier.volume68
dc.languageEnglish
dc.language.isoen_US
dc.publisherSpringer Heidelbergen_US
dc.relation.ispartofEuropean Journal Of Clinical Pharmacology
dc.sourceWeb Of Science (ISI)
dc.subjectPaediatric clinical trialsen_US
dc.subjectAdverse drug reactions (ADRs)en_US
dc.subjectDrug safetyen_US
dc.subjectData safety monitoring boards (DSMBs)en_US
dc.subjectSystematic reviewen_US
dc.titleSystematic review of safety in paediatric drug trials published in 2007
dc.typeReviewen_US
dspace.entity.typePublication

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