DEC-net: Il registro Europeo degli studi clinici pediatrici: I primi 200 protocolli inseriti

Translated title of the contribution: The European registry of RCT in paediatrics

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

DEC-net, the European register of pediatric clinical trials, has collected information on 200 studies that are planned or underway in France, Italy, Spain, or the United Kingdom. A population of about 45000 children is potentially represented in these trials. The majority of the studies are experimental (80%), and half of these are Phase III trials. In general, there is an even distribution of national single-center, national multi-center, and international trials in the register, but there are wide differences between the four countries. The most common types of diseases involved in the trials are neoplasms (17%; mainly leukemia), and blood and blood-forming organ diseases (mainly coagulation factor deficiencies), respiratory diseases (mainly asthma), and infectious diseases (9% each). The well recognized lack of scientific evidence on the safety and efficacy of drugs in children makes the international initiatives aimed at increasing access to information fundamental for improving the situation. DEC-net's activity, through its monitoring of ongoing studies, gives the register the potential to help avoid trial duplication and can facilitate a more proper distribution of funds based on the unmet therapeutic needs of children.

Original languageItalian
Pages (from-to)408-410
Number of pages3
JournalGiornale Italiano di Farmacia Clinica
Volume19
Issue number4
Publication statusPublished - Oct 2005

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Registries
Pediatrics
Deficiency Diseases
Access to Information
Blood Coagulation Factors
Financial Management
Spain
Italy
France
Communicable Diseases
Leukemia
Asthma
Clinical Trials
Safety
Pharmaceutical Preparations
Population
Neoplasms
Therapeutics
United Kingdom

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

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title = "DEC-net: Il registro Europeo degli studi clinici pediatrici: I primi 200 protocolli inseriti",
abstract = "DEC-net, the European register of pediatric clinical trials, has collected information on 200 studies that are planned or underway in France, Italy, Spain, or the United Kingdom. A population of about 45000 children is potentially represented in these trials. The majority of the studies are experimental (80{\%}), and half of these are Phase III trials. In general, there is an even distribution of national single-center, national multi-center, and international trials in the register, but there are wide differences between the four countries. The most common types of diseases involved in the trials are neoplasms (17{\%}; mainly leukemia), and blood and blood-forming organ diseases (mainly coagulation factor deficiencies), respiratory diseases (mainly asthma), and infectious diseases (9{\%} each). The well recognized lack of scientific evidence on the safety and efficacy of drugs in children makes the international initiatives aimed at increasing access to information fundamental for improving the situation. DEC-net's activity, through its monitoring of ongoing studies, gives the register the potential to help avoid trial duplication and can facilitate a more proper distribution of funds based on the unmet therapeutic needs of children.",
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author = "Chiara Pandolfini and Maurizio Bonati",
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AU - Bonati, Maurizio

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N2 - DEC-net, the European register of pediatric clinical trials, has collected information on 200 studies that are planned or underway in France, Italy, Spain, or the United Kingdom. A population of about 45000 children is potentially represented in these trials. The majority of the studies are experimental (80%), and half of these are Phase III trials. In general, there is an even distribution of national single-center, national multi-center, and international trials in the register, but there are wide differences between the four countries. The most common types of diseases involved in the trials are neoplasms (17%; mainly leukemia), and blood and blood-forming organ diseases (mainly coagulation factor deficiencies), respiratory diseases (mainly asthma), and infectious diseases (9% each). The well recognized lack of scientific evidence on the safety and efficacy of drugs in children makes the international initiatives aimed at increasing access to information fundamental for improving the situation. DEC-net's activity, through its monitoring of ongoing studies, gives the register the potential to help avoid trial duplication and can facilitate a more proper distribution of funds based on the unmet therapeutic needs of children.

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