A systematic review of paediatric randomised controlled drug trials published in 2007.
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.
Aripin
Khairun N B Nor
KN
Academic Division of Child Health, School of Graduate Entry Medicine and Health Sciences, University of Nottingham, Derby, UK. mgxknbn@nottingham.ac.uk
Choonara
Imti
I
Sammons
Helen M
HM
D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D003906:Developing Countries; D004358:Drug Therapy / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data