Prospective study of understudied drugs in children
Research type
Research Study
Full title
Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care
IRAS ID
142341
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2013-004642-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
This is a pragmatically designed study to gather more information on drugs currently prescribed and used in routine practice where there is not enough data to currently support a formal drug licence.
Only a small percentage of marketed approved drugs have sufficient pediatric data to support approval for childrens' use. The biochemical and physiological effect of drugs on the body normally differ between children and adults as well as within children according to pediatric age groups and special populations. Existing gaps place children at risk for adverse events and potential therapeutic failure. The purpose of this study is to understand the biochemical and physiological effects of understudied drugs in childrens' bodies. We are interested in how much drug the child is exposed to, as it may be higher or lower than an adult with the same condition, and this will help us to understand the biochemical and physiological effects. This study does not directly look at the physiology.This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0086
Date of REC Opinion
27 Feb 2015
REC opinion
Unfavourable Opinion