Role of CVBF



INCiPiT is a network composed by the main Italian Paediatric Hospitals and Scientific Institutes for Research, Hospitalization and Health Care (IRCCS) and other Institutions, coordinated by Ospedale Pediatrico Bambino Gesù IRCCS, aimed to promote and support the conduction of all types of clinical trials in the paediatric population by all kinds of sponsor (academic investigators, pharmaceutical industries, contract research organisations).

Clinical research in paediatric population has to face many difficulties, such as lack of funds, suitable infrastructures and specific competences. Therefore, off label or unlicensed administration of drugs in every day paediatric practice is still frequent. To overcome this lack of appropriate medicines for children, the new Paediatric Regulation established the requirement for pharmaceutical industry to conduct paediatric studies on medicinal products considered essential and needed in the treatment of paediatric diseases.

The aim of INCiPiT is to encourage high-quality research on drugs in children in Italy creating competences and guidelines to support paediatric clinical trials, harmonizing joint national operational models, providing training activities, and involving children and young people and their families in the paediatric research.

Among the main initiatives, the TEDDY Network in collaboration with INCiPiT, has launched a survey to map the INCiPiT centres and provide an overview of the experience and potentiality of the paediatric clinical research centres in Italy. The survey is aimed to collect all kind of expertise of services, cross-competences, equipment to support the planning, conduct and completion of paediatric clinical trials.



Actually, INCiPiT counts for 21 Partners:

  • the main Italian Paediatric Hospitals and Scientific Institutes for Research, Hospitalization and Health Care (IRCCS): Ospedale Pediatrico Bambino Gesù IRCCS; Istituto Giannina Gaslini IRCCS; Istituto per l’Infanzia Burlo Garofolo IRCCS; Azienda Ospedaliero-Universitaria Meyer; A.O.U. Regina Margherita, città della Salute e della Scienza di Torino; ASST Spedali Civili di Brescia; Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari; Ospedale dei Bambini Buzzi; U.O. di Neonatologia e Terapia Intensiva Neonatale Clinica Mangiagalli e Clinica Pediatrica De Marchi- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università di Milano; Dipartimento Salute Della Donna E Del Bambino, Università Di Padova; A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli, Palermo; Clinica di Neuropsichiatria dell’Infanzia e dell’Adolescenza Azienda Ospedaliera “G.Brotzu” di Cagliari; Azienda Ospedaliera di Rilievo Nazionale (AORN) “Santobono Pausilipon” di Napoli;
  • networks operating in paediatric research: PRINTO, CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche), TEDDY (European Network of Excellence for Paediatric Clinical Research), AIEOP, PEDIANET, ECAPN.