The possibility of accessing data from the daily activities of paediatric general practitioners and family paediatricians is a unique resource, both for studying individual diseases, as well the interactions between different areas of health care and population health.
Since 1998 there has been a system to collect epidemiological information for clinical research from family paediatricians (Pedianet) in Italy.
This system is based on the transmission of specific data (determined by individual studies) from computerised clinical files, which the paediatricians in the network fill out during their daily professional activities. Informed consent is required from the parents. Such data is collected anonymously by a central server in Padua, where it is validated and elaborated.
Pedianet is an independent network. The coordination of the projects and data analysis are carried out by a scientific committee that include internationally reknown paediatricians, epidemiologists and researchers. Approximately 300 paediatricians throughout the country have taken part in Pedianet projects (see complete list).
Over 20 clinical epidemiological studies on major paediatric diseases or pharmacovigilance have been carried out or were ongoing up to June 2006. These studies have resulted in over 50 publications on international magazines and presentations at conferences.
Studies carried out to-date have been financed by public bodies (European Commission, Istituto Superiore di Sanità, AIFA, Consiglio Nazionale delle Ricerche, Regione Veneto, Aziende Socio Sanitarie, Istituto Zooprofilattico delle Venezie) or private groups such as pharmaceutical companies or international research groups. Each project is guided by an agreement between the “sponsor” and Pedianet which always includes publication of the study.
From January 2007, a new law has made it mandatory to present a Paediatric Investigation Plan to EMEA to obtain a paediatric licence.
There are also a number of incentives for companies obtaining a paediatric licence for drugs which are already on the market, both under patent and “off patent”.
In the last few months the new European legislature has brought about important developments in paediatric clinical research.
The role of Pedianet, not just as a database (especially for pharmacovigilance studies), but as an organised structure in which different competencies converge, is essential in this new context.
This is confirmed by the presence and participation of Pedianet in important European projects, such as TEDDY as well as by the increasing interest European institutions, research groups and pharmaceutical companies are showing to collaborate with Pedianet.