原创力文档ocular medicines in children the regulatory situation related to clinical research眼部药物在儿童监管情况相关的临床研究.pdfVIP
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ocular medicines in children the regulatory situation related to clinical research眼部药物在儿童监管情况相关的临床研究
Fortinguerra et al. BMC Pediatrics 2012, 12:8
/1471-2431/12/8
RESEARCH ARTICLE Open Access
Ocular medicines in children: the regulatory
situation related to clinical research
*
Filomena Fortinguerra , Antonio Clavenna and Maurizio Bonati
Abstract
Background: Many ocular medications are prescribed for paediatric patients, but the evidence for their rational
use is very scant. This study was planned to compare the availability and the licensing status of ocular medications
marketed in Italy, the United Kingdom (UK), and the United States of America (USA) related to the amount of
published and un-published RCTs testing these drugs in the paediatric population.
Methods: A quantitative analysis was performed to evaluate the number of ocular medications with a paediatric
license in Italy, the UK, and the USA. A literature search was also performed in MEDLINE, EMBASE, and The
Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) on ophthalmic
pharmacological therapy in children aged 18 years, published up to December 2010. A search in the
international clinical trial registries, the list of paediatric investigation plans (PIPs) approved by European Medicines
Agency (EMA), and the table of medicines with new paediatric information approved by Food and Drug
Administration (FDA) was also performed.
Results: In all, of 197 drugs identified, 68 (35%) single drugs are licensed for paediatric use at least in one
considered country, while 23 (12%) were marketed in all three countries. More specifically, in Italy 43 single drugs
(48% of those marketed) had a paediatric license, while 39 (64%) did in the UK and 22 (54%) did in the USA. Only
13 drugs were marketed with a paediatric license in all countries.
The percentage of drugs licensed for paediatric use and fo
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