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The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial

Carrol Gamble ; Andrew Wolf ; Ian Sinha ; Catherine Spowart ; Paula Williamson

PLoS ONE, 01 January 2013, Vol.8(3), p.e51787 [Periódico revisado por pares]

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  • Título:
    The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial
  • Autor: Carrol Gamble ; Andrew Wolf ; Ian Sinha ; Catherine Spowart ; Paula Williamson
  • Assuntos: Sciences (General)
  • É parte de: PLoS ONE, 01 January 2013, Vol.8(3), p.e51787
  • Descrição: BACKGROUND:Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. METHODOLOGY/PRINCIPAL FINDINGS:The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched...
  • Idioma: Inglês

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