Reactions 1413 - 4 Aug 2012

Paediatric patients under-represented in clinical trials

Paediatric patients are greatly under-represented inclinical trial research despite a major paediatric burdenof disease, an analysis of registered clinical trials hasfound.1

The study authors used WHO data to identify the fiveconditions with the highest disease burden amongchildren in high-income countries and amongdeveloping countries, and identified all of the recentdrug intervention studies for these high-burden diseasesthat were registered on ClinicalTrials.gov (starting in2006 or later). Overall, despite a paediatric diseaseburden of 60%, only 12% of trials were conducted inpaediatric patients. Paediatric studies were found to beprimarily funded by government and non-profitorganisations, which may have limited budgets for theconduct of clinical trials, rather than by pharmaceuticalcompanies. The authors also noted that there wererelatively fewer studies in paediatric patients whichfocussed on, or included, pharmacokinetic/pharmacodynamic and safety assessments.

"Children are severely underrepresented in clinicalresearch, despite several national and global effortsaimed at addressing their medical needs," said authorKenneth Mandl in a media release that accompanied thepublication,2 adding that "without proper information onpediatric safety and efficacy, doctors are often left withlittle choice but to extrapolate from adult studies".1. Bourgeois FT, et al. Pediatric Versus Adult Drug Trials for Conditions With

High Pediatric Disease Burden. Pediatrics 130: 285-292, No. 2, 26 Jul 2012.2. Boston Childrens Hospital. Drug safety and efficacy in children is rarely

addressed in drug trials for major diseases. Media Release : 23 Jul 2012.Available from: URL: http://www.childrenshospital.org.

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Reactions 4 Aug 2012 No. 14130114-9954/10/1413-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved