Systematic review of safety in paediatric drug trials published in 2007
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 adve...
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| Format: | Article |
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Springer Verlag
2012
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| Online Access: | https://eprints.nottingham.ac.uk/2579/ |
| _version_ | 1848790821686476800 |
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| author | Nor Aripin, Khairun Nain Bin Choonara, Imti Sammons, Helen |
| author_facet | Nor Aripin, Khairun Nain Bin Choonara, Imti Sammons, Helen |
| author_sort | Nor Aripin, Khairun Nain Bin |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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 |
| first_indexed | 2025-11-14T18:18:43Z |
| format | Article |
| id | nottingham-2579 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T18:18:43Z |
| publishDate | 2012 |
| publisher | Springer Verlag |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-25792020-05-04T20:21:53Z https://eprints.nottingham.ac.uk/2579/ Systematic review of safety in paediatric drug trials published in 2007 Nor Aripin, Khairun Nain Bin Choonara, Imti Sammons, Helen 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 Springer Verlag 2012-02 Article PeerReviewed Nor Aripin, Khairun Nain Bin, 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 Paediatric clinical trials Adverse drug reactions Drug safety Data safety monitoring boards Systematic review http://link.springer.com/article/10.1007%2Fs00228-011-1112-6 doi:10.1007/s00228-011-1112-6 doi:10.1007/s00228-011-1112-6 |
| spellingShingle | Paediatric clinical trials Adverse drug reactions Drug safety Data safety monitoring boards Systematic review Nor Aripin, Khairun Nain Bin Choonara, Imti Sammons, Helen Systematic review of safety in paediatric drug trials published in 2007 |
| title | Systematic review of safety in paediatric drug trials published in 2007 |
| title_full | Systematic review of safety in paediatric drug trials published in 2007 |
| title_fullStr | Systematic review of safety in paediatric drug trials published in 2007 |
| title_full_unstemmed | Systematic review of safety in paediatric drug trials published in 2007 |
| title_short | Systematic review of safety in paediatric drug trials published in 2007 |
| title_sort | systematic review of safety in paediatric drug trials published in 2007 |
| topic | Paediatric clinical trials Adverse drug reactions Drug safety Data safety monitoring boards Systematic review |
| url | https://eprints.nottingham.ac.uk/2579/ https://eprints.nottingham.ac.uk/2579/ https://eprints.nottingham.ac.uk/2579/ |