Systematic review of safety in paediatric drug trials published in 2007
Nor Aripin, Khairun Nain Bin and Choonara, Imti and Sammons, Helen (2012) Systematic review of safety in paediatric drug trials published in 2007. European Journal of Clinical Pharmacology, 68 (2). pp. 189-194. ISSN 0031-6970
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.
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