Drug toxicity in children: paediatric randomised controlled drug trials and global child health
Concern with potential toxicity due to the widespread use of unlicensed and off label drugs in children has led to regulatory changes aimed to strengthen the evidence base for paediatric drugs. This thesis examines paediatric randomised controlled trials (RCTs), the highest level of evidence, and as...
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| Format: | Thesis (University of Nottingham only) |
| Language: | English |
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2010
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| Online Access: | https://eprints.nottingham.ac.uk/11506/ |
| _version_ | 1848791292992028672 |
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| author | Nor Aripin, Khairun Nain Bin |
| author_facet | Nor Aripin, Khairun Nain Bin |
| author_sort | Nor Aripin, Khairun Nain Bin |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Concern with potential toxicity due to the widespread use of unlicensed and off label drugs in children has led to regulatory changes aimed to strengthen the evidence base for paediatric drugs. This thesis examines paediatric randomised controlled trials (RCTs), the highest level of evidence, and assesses them in relation to global child health.
A systematic review was performed using validated methods to search three major databases for paediatric RCTs published in 2007. More than 600 RCTs were identified involving more than 100,000 children. The RCTs appear to study the appropriate clinical areas however few studies involved neonates. The RCTs also seem to be of good methodological quality with a mean Jadad score of 3.22.
The reporting of RCTs that involve both adults and children needs to be improved to add to the evidence base of paediatric medicines. More attention is also needed on the reporting of safety information from the RCTs to provide useful toxicity data. Although severe and moderate ADRs were seen in 25% of the RCTs, few RCTs (12%) established safety monitoring committees (SMCs). SMCs are vital to ensure patients in paediatric RCTs are protected from toxicity.
The burden of childhood disease is heaviest in low and middle income countries (LMIC). A minority of the RCTs were performed in LMIC, although they are increasingly globalised. RCTs conducted in LMIC appear to have lower methodological quality, and reported less well on ethical approval and adverse events.
In conclusion high quality, ethical paediatric RCTs should add to the evidence base for paediatric medicines. However they should correspond with the health needs of children on a global basis. |
| first_indexed | 2025-11-14T18:26:12Z |
| format | Thesis (University of Nottingham only) |
| id | nottingham-11506 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T18:26:12Z |
| publishDate | 2010 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-115062025-02-28T11:13:55Z https://eprints.nottingham.ac.uk/11506/ Drug toxicity in children: paediatric randomised controlled drug trials and global child health Nor Aripin, Khairun Nain Bin Concern with potential toxicity due to the widespread use of unlicensed and off label drugs in children has led to regulatory changes aimed to strengthen the evidence base for paediatric drugs. This thesis examines paediatric randomised controlled trials (RCTs), the highest level of evidence, and assesses them in relation to global child health. A systematic review was performed using validated methods to search three major databases for paediatric RCTs published in 2007. More than 600 RCTs were identified involving more than 100,000 children. The RCTs appear to study the appropriate clinical areas however few studies involved neonates. The RCTs also seem to be of good methodological quality with a mean Jadad score of 3.22. The reporting of RCTs that involve both adults and children needs to be improved to add to the evidence base of paediatric medicines. More attention is also needed on the reporting of safety information from the RCTs to provide useful toxicity data. Although severe and moderate ADRs were seen in 25% of the RCTs, few RCTs (12%) established safety monitoring committees (SMCs). SMCs are vital to ensure patients in paediatric RCTs are protected from toxicity. The burden of childhood disease is heaviest in low and middle income countries (LMIC). A minority of the RCTs were performed in LMIC, although they are increasingly globalised. RCTs conducted in LMIC appear to have lower methodological quality, and reported less well on ethical approval and adverse events. In conclusion high quality, ethical paediatric RCTs should add to the evidence base for paediatric medicines. However they should correspond with the health needs of children on a global basis. 2010-10-15 Thesis (University of Nottingham only) NonPeerReviewed application/pdf en arr https://eprints.nottingham.ac.uk/11506/1/COMPLETE_THESIS.pdf Nor Aripin, Khairun Nain Bin (2010) Drug toxicity in children: paediatric randomised controlled drug trials and global child health. PhD thesis, University of Nottingham. |
| spellingShingle | Nor Aripin, Khairun Nain Bin Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title | Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title_full | Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title_fullStr | Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title_full_unstemmed | Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title_short | Drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| title_sort | drug toxicity in children: paediatric randomised controlled drug trials and global child health |
| url | https://eprints.nottingham.ac.uk/11506/ |