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.
|Translated title of the contribution||The European registry of RCT in paediatrics|
|Number of pages||3|
|Journal||Giornale Italiano di Farmacia Clinica|
|Publication status||Published - Oct 2005|
ASJC Scopus subject areas
- Pharmacology (medical)