Paediatric investigation plans for pain: painfully slow!
OBJECTIVE
To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA).


METHODS
Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis.


RESULTS
Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products.


CONCLUSIONS
The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain.
Davies
Elin H
EH
Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.
Ollivier
Cecile M
CM
Saint Raymond
Agnes
A
D000293:Adolescent; D026683:Advisory Committees; D000700:Analgesics / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D007883:Legislation, Medical; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence; D010146:Pain / Q000188:drug therapy*; D010372:Pediatrics / Q000331:legislation & jurisprudence* / Q000592:standards
D000700:Analgesics
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15687423
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19484828
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19703675
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19936724