A systematic review of paediatric randomised controlled drug trials published in 2007.

Abstract:

OBJECTIVE:To elucidate the current situation of randomised drug trials involving the paediatric population. METHODS:Systematic review of paediatric randomised controlled trials of medicinal products published in 2007. Three major databases were searched with validated search strategies; Medline, Embase and Cochrane Central Register of Controlled Clinical Trials. Data was collected on the location, participants, class of drug and methodological quality of the trials. RESULTS:Six hundred and four trials were found involving more than 100,000 paediatric participants. Only about a quarter (146, 24%) were conducted in low and lower-middle income countries. Few studies (42, 7%) were performed in neonates. Many trials recruiting both adult and paediatric patients inadequately describe the characteristics of the paediatric participants. The most studied areas were nervous system (155, 26%), anti-infective (101, 17%) respiratory (74, 12%) or antiparasitic (45, 8%) drugs. A high proportion of the studies (36%) used an inactive placebo as the comparator. Paediatric randomised drug trials performed in low and low-middle income countries were of lower methodological quality (mean Jadad score 2.90 vs 3.27, p<0.01), studied more antiparasitic and anti-infectives (47% vs 16%, p<0.01) but fewer reported that ethical approval was obtained (83% vs 93%, p<0.01), compared to those conducted in high or upper-middle income countries. CONCLUSIONS:There are a significant number of randomised controlled drug trials involving children taking place throughout the world. To develop the evidence base for safe and effective medicines for the benefit of the whole paediatric population, high quality and ethical clinical trials should involve a wide range of children.

journal_name

Arch Dis Child

authors

Aripin KN,Choonara I,Sammons HM

doi

10.1136/adc.2009.173591

subject

Has Abstract

pub_date

2010-06-01 00:00:00

pages

469-73

issue

6

eissn

0003-9888

issn

1468-2044

pii

adc.2009.173591

journal_volume

95

pub_type

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