Currently only 30% of drugs used in paediatrics in Europe are licensed for use in children. The reason for this is the ethical difficulty and scientific complexity of research in paediatrics and the lack of any financial incentive for the pharmaceutical industries to invest in research aimed at drugs with a restricted market. To try to overcome these difficulties the European parliament and EMEA finally published a new set of paediatric regulation which requires any new drug to give a Pediatric Investigation Plan to EMEA for paediatric registration. There are also a series of incentives for companies who obtain paediatric registration of drugs already on the market, both patented and off patent.
The new European legislation has recently brought interesting developments in clinical paediatric research. Pedianet’s role, not just as a database, but also as an organised structure in which numerous competencies meet, is essential. This has been confirmed by Pedianet’s participation in projects of great scientific interest such as TEDDY, and by the growing interest of european institutions, research groups and pharmaceutical companies to collaborate with Pedianet.
TEDDY (Task-force European Drug Development for the Young is a european network of excellence, financed since 2005 (and until 2010) by the European Commission as part of the Sixth Framework Programme for Research and Technological Development, FP6.
The project involves 19 partners from 9 EU member countries, Romania and Israel. It has the purpose of promoting the availability of safe and effective paediatric drugs, integrating new activity with current experience and good practice to fill the void in scientific studies specifically addressing drugs for paediatric use.
In this new European horizon Teddy aims to work for the development of paediatric research on drugs integratine clinical competencies with epidemiological, pharmacological, methodological, ethical and other competencies.
TEDDY currently occupies a central position in European Paediatric research and is recognized by the European Commission and EMEA as the technical and organizational reference point in strategic projects of collaboration with other main players (pharmaceutical companies, research groups, patient groups, etc).
The specific objectives of the network are:
1.Create guidelines for the safe and efficient use of drugs in children based on development pharmacology, pharmacogenetics and pharmacogenomics.
2.Identify needs in the use of drugs in paediatrics (in collaboration with the paediatric committee of EMEA)
3.Evaluate the efficacy of methodologies used to study the safety and efficacy of drugs in paediatrics
4.Verify and consolidate the current knowledge of existing drugs being usedin paediatrics and create a european database with the informaton on drugs registeres for use in children.
5.approfondire e valutare le problematiche etiche relative alla sperimentazione in pediatria.
6Favour the development of new paediatric drugs, coordinating the collaboration between pharmaceutical companies, researchers, patient groups and regulatory bodies.
These objectives will be reached through a programme of activities, formulated as a series of
workpackages (see www.teddyoung.org).
One of TEDDY’s main activities is pharmacoepidemiologial studies to study the prescriptive (prescrittive) characteristics of different drugs in different european countries and pharmacovigilance in paediatrics.
Various databases (GPRD, IMCI, IMS e Pedianet) will be used for these research activities ( included in workpackage 1). The data will be analysed by a group of European pharmacoepidemiology experts coordinated by Prof Ian Wong of the Institute of Child Health in Londra and Dr. Miriam Sturkenboom of the Department of Epidemiology e Biostatistics of Rotterdam.
Although Pedianet contains information on a lesser number of children than GPRD or IMCI, the characteristics of the information contained on Pedianet (diagnosis, reasons for access, free text, etc) make it a unique tool to carry out studies within the TEDDY framework.
Some preliminary analysis on caratteristiche prescrittive have already been carried out and the results presented confidentially in various meetings. A few scientific publications are being currently prepared.