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. 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.
Scientific Commitee
- Luigi Cantarutti (Pedianet Coordinator), Pediatrician, Padova
- Carlo Giaquinto (Pedianet Coordinator), University of Padua - Department of Pediatrics
- Paola Baiardi, Director of CVBR.
- Adriana Ceci, University of Bari.
- Gobbi Costantino, Pediatrician, Macerata
- Girotto Silvia, Pediatrician, Venezia
- Alfredo Nicolosi, Director of Dipartimento Epidemiologia and Informatica Medica, CNR, Milano.
- Rocchi Francesca, European Assessment Unit - Italian Medicine Agency (AIFA)
- Paolo Rossi, University di Tor Vergata, Roma;
- Miriam Sturkenboom, President of International Society Pharmacoepidemiology
Statistical Analysis
Anna Cantarutti
Ph.D.
Laboratory of Healthcare Research and Pharmacoepidemiology
Department of Statistics and Quantitative Methods
University of Milano-Bicocca
Data Monitor
Antonio Scamarcia, Società Servizi Telematici, Padova
Computer-related Assistance
Alessandro Zandarin, Società Servizi Telematici, Padova
List of the Pediatricians who partecipated to the Pedianet projects
Abruzzo
Balzamo Giacinto, Bonfigli Emanuela, Cavallo Fausto, Collacciani Giuseppe, Di Renzo A. Paola, Di Saverio Piero, D'Onofrio Vincenzo, Ferretti Michele, Forcina Paolo, Fracassi Americo, Letta M. Rosaria, Lucantonio Ricciardo, Magnelli Alessandra, Napoleone Maria, Palma Maria Maddalena, Ruscitti AnnaMaria, Venditti Sergio.
Campania
Antonucci Eleonora, Basile Paola, Bratto Massimo, Castaldo Annunziata, Conte Ugo Alfredo, Coronella Angelo, Costanzo Nicola, Di Santo Giuseppe, D'Onofrio Antonietta, Falco Pietro, Ferraiuolo Maurizio, Mariniello Lorenzo, Marino Antonio, Petrazzuoli Giovanni, Speranza Francesco, Sticco Maura, Tambaro Paolo, Volpe Giuseppina.
Emilia-Romagna
Alberti Arturo, Barone Roberto, Bartoli Gianni, Biondi Claudio, Cafaro Carla, Cappelli Valentina, Caracalla Maura, Casalboni Rita, CeronUgo, Cucchi Cinzia, Davoli Anna Maria, Donati Daniela, Faberi Paolo, Faedi Clara Maria, Gherardi Eugenio, Guerra Ledda, Hamarneh Marwan, Lusoli Roberto, Mazzini Franco, Parolini Anna, Pistocchi Simonetta, Ponti Roberto, Prodi Miriam, Reggiani Lamberto, Trebbi Miro, Varni Pierfiorenzo, Villani Lina.
Friuli-Venezia Giulia
Andreello Luisa, Besoli Giancarlo, Cristiani Donatella, De Clara Roberto, Di Francesco Giovanna, Fain Simonetta, Lorusso Giuseppe, Masotti Sergio, Montanari Giuseppe, Muzzolini Carmen, Nicoloso Flavia, Rosenwirth Daniela, Toscano Cristina, Ulliana Antonella.
Lazio
De Angelis Rita, De Berardinis Marcella, Lorson Dominique, Napolitano Salvatore, Tanzi Ivo.
Liguria
Bezzi Roberto, Brusoni Guido, Rampini Luigina.
Lombardia
Battilana Maria Pia, Cagliani Anna, Camposarcone Mafalda, Clerici Schoeller Mariangela, Corbetta Daniela, Corrini Luisa Maria, Curto Salvatore, D'Ambrosa Antonio, De Angelis Monica, Dusi Daniela, Elio Giuseppe, Filiberti Gianfranco, Frattini Claudio, Lando Isaia, Lietti Giuseppe, Maioli Ferdinando, Mauri Laura, Picco Patrizia, Pirola Ambrogina, Ragazzon Ferdinando, Rosignoli Rino, Russo Annarita, Spinelli Bruno, Terenghi Albino, Tusa Antonino, Vailati Marina, Vannini Paola, Vertua Guido, Villella Anna, Zanetto Federica.
Marche
Bari Savio, Bartolucci Eleonora, Bollettini Stefano, Bottiglieri Aurora, Braico Giuseppe, Bravetti Emanuela, Budassi Roberto, Capolongo Alessandro, Cicione Giuseppe, Cristofanelli Palmina, De Angelis Massimo, Di Chiara Gabriella, Dolci Marco, Galvagno Andrea, Garbuglia Gabriele, Gentili Alberta, Gentilucci Pierfrancesco, Gobbi Costantino, Grelloni Mauro, Grugnetti Mirco, Lorenzini Lorella, Lucchetti Andrea, Lupini Anna, Marconi Carlo, Maurizi Maurizio, Migliori Cesare, Olimpi Laura Maria, Pallottini Silvana, Pellegrini Lucia, Piazzini Claudio, Ragaglia Patrizia, Scuppa Ubaldo, Senesi Paolo, Tonelli Gabriele.
Piemonte
Amadio Franco, Artusio Sergio, Basso Mirella, Bruna Andrea, Bruno Eleonora, Calori Antonella, Candido Maurizio, Caramello Massimo, Comaita Fabrizio, Fantino Nella, Felicioni Walter, Gambotto Silvia, Marchetto Giuseppina, Mauro Giorgio, Mirabelli Maria Cristina, Mondino Manuela, Pessino Paola, Pistone Giovanni, Santoro Maria Ausilia, Sciolla Nico Maria, Spinelli Franca, Tavassoli Kaveh, Valpreda Andrea.
Puglia
Antonaci Maria, Calà Angela, Cazzato Teresa, Randolfi Teresa, Santoro Antonio, Vitale Alfredo.
Sardegna
Basoccu Pietro, Cera Giuseppe Egidio, Cossu Patrizia, Cuboni Giancarlo, Lazzari Maura, Mulas Anna, Pani Paola Maria, Pazzola Pasquale, Rosas Paolo.
Sicilia
Alongi Angelo, Avarello Giovanni, Barberi Frandanisa Maria, Campo Mario, Cumella Antonino, Faraci Marco, Lo Bianco Mario, Migliore Patrizia, Moscato Vincenzo, Petrotto Giuseppe, Puma Antonino, Salamone Pietro, Speciale Sergio, Vella Rosa Giuseppa, Volpe Concetta.
Toscana
Baggiani Adriana, Barsotti Ferruccio, Frontini Enrico Luciano, Massai Ugo, Pucci Catia, Riotta Roggi Adele, Rolla Mario, Storelli Francesco.
Trentino-Alto Adige
Leveghi Maria Rosaria.
Veneto
Andreotti Maria Francesca, Andrighetto Gilberto, Baldin Francesco, Balliana Franco, Baraldo Robertino, Barbazza Maria Carolina, Barbieri Patrizia, Battaglini Giovanni, Beccaro Francesca, Belluzzi Gabriele, Benetti Eleonora, Bernuzzi Marco, Bonaiuto Francesco, Bonati Saverio, Bordin Antonella, Borghesani Marisa, Boscolo Roberto, Brusaterra Ivana, Brutti Paolo, Bucolo Carmelo, Bussi Roberto, Cantarutti Luigi, Carnazza Silvia, Carraro Federica, Caserta Antonio, Cavedagni Monica, Chiesa Mario, Chirco Maria, Cozzani Sandra, Dal lago Lorenzo, Dal Zio Maria, D'Amanti Vito Francesco, De Marchi Annamaria, De Santi Marilena, Del Torso Stefano, Dell'Antonia Fabio, Denes Franca, Doria Mattia, Drago Stefano, Esposito Giorgio, Fabriano Giovanni, Fama Mario, Felice Michele, Ferrara Enrico, Fornasari Silvia, Fumaneri Fabrizia, Fusco Fabrizio, Gallo Giovanni, Geremia Valeria, Giancola Giuseppe, Girgenti Calogero, Girotto Silvia, Gobbi Patrizia, Grillone Giuseppe, Ieva Angela, Iuliano Maria, Katende Mulopo, Lancellotti Laura, Lemma Carlo, Liotti Giuseppe, Lista Cinzia, Lovison Loredana, Luchelli Roberta, Luise Francesco, Macropodio Nadia, Marchese Paolo, Marinucci Nicoletta, Mastroprimiano Silvana, Mattiazzo Paola, Matticchio Giuliana, Mazzi Marco, Menegus Elena, Meo Antonio, Miglioranzi Giampaolo, Milani Massimo, Monicelli Ugo, Montini Camilla, Murgia Vitalia, Naso Immacolata, Neidhart Carlo, Parolini Gianpaolo, Pasinato Angela, Pasquato Stefano, Passarella Andrea, Perin Stefania, Pisetta Franco, Pittarello Daniele, Righetti Andrea, Risdonne Giampaolo, Ruffato Bruno, Sambugaro Daniela, Sardei Daniela, Saretta Luigi, Sassolino Stefania, Schievano Paolo, Semenzato Flavio, Serragiotto Renata, Signorini Rita, Silvan Carla, Soraci Carlo, Spacagna Francesco, Spanevello Walter , Stefani Daniela, Tamassia Gianni, Tapparello Gianantonio, Toderini Luisa, Toffol Giacomo, Tommasi Mara, Vallone Graziano, Zanette Marco, Zuccolo Maria