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Registered paediatric trials worldwide: frequency, location and focus

Date and Location




Saturday 21 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Patrina Caldwell

Contact person

Patrina Caldwell
Abstract text
Background: The need for more, better, and relevant paediatric clinical trials have been recognised internationally with several initiatives underway to fix these gaps, but the current status of trials involving children is unclear. Objective: To describe and evaluate the spectrum of registered paediatric clinical trials on the World Health Organisation International Clinical Trials Registry Platform (ICTRP). Methods: All clinical trials on ICTRP from 2000 to 2012 were reviewed. Data extracted included the number of paediatric (0−18 years) and adult trials, medical conditions treated, intervention type, funding sources, and location (classified by country). Results: Overall 16.7% (31587/189592) of registered trials are paediatric trials. The proportion of paediatric trials have decreased from 22.9% in 2000 to 15.4% in 2012. However, the total number of trials overall have increased from 484 in 2000 to 4514 in 2012. There are significantly fewer paediatric trials conducted in low to middle income countries compared to high income countries (21.8% of trials), considering that 89.3% of children live in those countries. Paediatric trials in low to middle income countries focussed on respiratory problems (630, 9.2%), malaria (422, 6.1%), HIV (386, 5.6%), perinatal health (360, 5.2%) and cancer (321, 4.7%) and trials in high income countries focussed on cancers (2447, 9.9%), respiratory health (2360, 9.5%), musculoskeletal diseases (1645, 6.6%), infections (1203, 4.9%) and metabolic/endocrine diseases (1074, 4.3%). The majority of registered paediatric trials were pharmaceuticals trials (10509, 33.3% of trials). Slightly more paediatric trials were sponsored by the pharmaceutical industry compared with adults (4116, 13.0% vs 19623, 12.4%, p=0.002). Conclusion: Although the total number of trials have increased, there remains disproportionately fewer paediatric trials compared with adult trials, particularly in low to middle income countries, with many pharmaceutical sponsored trials. The focus of the trials seems appropriate to the disease burden faced by children in those countries.