Bambino Gesù is the largest paediatric hospital and research center in Europe, with connections to leading international centers in the sector. Bambino Gesù hospital has a staff of almost 2,600 including physicians, researchers, nurses, clinical technicians and office staff.
The Hospital treats and cares for a large number of patients: over 1.550.000 healthcare services are provided each year to children and adolescents from all over the world. Comparable to a city in its size, the hospital is inhabited by children who are treated, monitored and supported within an affordable, comprehensive and high-quality healthcare solution.
Ospedale Pediatrico Bambino Gesù is the Coordinator of INCiPiT. Within the Bambino Gesù Hospital, the Clinical Trial Center was established in January 2010 in order to meet the needs for conducting clinical trials for the paediatric use of medicines. It promotes excellence of clinical trials in paediatrics and provides researchers with the means needed for high quality clinical trials.
INCiPiT is composed by the main Italian Paediatric Hospitals and Scientific Institutes for Research, Hospitalization and Health Care (IRCCS) and other Institutions, such as disease-specific paediatric networks, which operate at different level in paediatric research.
Ospedale Pediatrico Bambino Gesù IRCCS
Istituto Giannina Gaslini IRCCS
The Giannina Gaslini Institute is a paediatric hospital located in Genoa founded in 1931 and recognized as a Scientific Institute for Research, Hospitalisation and Healthcare (IRCCS) in 1959. It is the biggest pediatric hospital in the North of Italy, with its 22 buildings and more than 2.000 employees, including physicians, nurses, university staff and researchers. All of the paediatric specialties are present, in addition to several labs and university courses. A specific university degree for paediatric nurses has been created.
The International Centre for Studies and Training G. Gaslini (CISEF) provides educational projects for medical doctors and all other healthcare professionals. The Institute receives thousands of children of ninety nationalities yearly, as well as over twenty thousand children from all Italian regions, which constitute around half of all its patients. The Gaslini Institute has over 30 Top Italian scientists among its staff according to the Via Academy (http://www.via-academy.org).
In the last five years the Gaslini hospital has conducted several sponsored trials (128 as of 2016) and investigator initiated trials (250 as of 2016) through all the specialities present in the hospital. The Scientific Direction oversees the design, management and analysis of investigator’s initiated trials and ethics committee submission of all the paediatric sponsored and investigator’s initiated trials as paediatric committee of the regional ethics committee.
Istituto per l'Infanzia Burlo Garofolo IRCCS
Burlo Garofolo is an Italian Scientific Institute for Research, Hospitalisation and Health Care located in Trieste, Northeastern Italy, recognized by the Italian National Ministry of Health for paediatric, maternal and women's health.
Translational research activities include the following main areas: Maternal and fetal medicine and neonatology, Chronic diseases with onset in paediatric age, Paediatric surgery and rehabilitation, Epidemiology, prevention, and quality of care, Paediatric neurosciences.
Since 1992 the Unit for Health Services Research and International Cooperation acts as a WHO Collaborating Centre for Maternal and Child Health.
Azienda Ospedaliero-Universitaria Meyer
The Meyer children’s university hospital (Azienda Ospedaliero-Universitaria Meyer - AOU Meyer) is a public hospital of Tuscany’s regional health service, with independence as regards its management, business development and organization. AOU Meyer ranks among Italy’s highly specialised hospitals for diagnosis, care and rehabilitation services for children, also being a national reference centre for complex cases, rare diseases, and surgery.
The hospital can offer up to 247 beds and its facilities employ leading-edge modern technology and children-tailored therapies, ensuring support for parents as well. Together with the University of Florence, it carries out health assistance, teaching and high-level research activities in paediatrics.
In pursuing its research goals, the hospital’s Clinical Trial Office (CTO), established in 2014, fosters independent research, guaranteeing crucial support services (study design, data collection and management, statistical analysis, administrative processing) and, moreover, it enhances both not-for-profit and sponsored clinical trials.
A.O.U. Regina Margherita, città della Salute e della Scienza di Torino ORIM
Regina Margherita Hospital is a children’s hospital which deals with the prevention, diagnosis and cure of children’s diseases. The Hospital has surgical, medical, and diagnostic specialities for the cure of babies, children and teenagers and it is the referral centre for the most complex and rare children’s diseases.
The areas of excellence at the Regina Margherita Children’s Hospital are high complexity surgery, cardiosurgery, neurosurgery, solid organ transplants, cardiology, onco-haematology, and haematopoietic stem cell transplantation. The Emergency Department takes care of all the urgent cases. All the specialists have specifically trained on these paediatric disciplines.
The Hospital includes the “S.C. Oncoematologia Pediatrica e Centro Trapianti” that has obtained an excellent national reputation as one of the leading centres for paediatric haemato-oncology and stem cell transplantation. It also performs translational and clinical research into specific fields of the different paediatric cancers.
- ASST Spedali Civili di Brescia
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari is a public institution with organizational and managerial autonomy from May 1st, 1996 and is included in the Regional and National Health System. It hosts the Faculty of Medicine and Surgery and encompasses since 2005 the Giovanni XXIII Paediatric Hospital, which is the largest and most important paediatric hospital and research center of the Apulia Region.
It collaborates as partner in many national and international research projects and their hospital and universities operating units are included in national and international research networks, among which TEDDY, the European Network of Excellence for Paediatric Clinical Research, thus providing qualified scientific expertise.
The Hospital is working to set up, through innovative and experimental management and organizational methods, a highly specialized and a reference paediatric research infrastructure, including a clinical trial center, both for the assistance and the research in the neonatal, paediatric and developmental clinical research field.
ASST Fatebenefratelli Sacco/Buzzi
The new istitution ASST (Azienda Socio Sanitaria Territoriale) Fatebenefratelli Sacco groups the following hospital unit: "Vittore Buzzi Children's Hospital ", "Luigi Sacco", " Macedonio Villoni" and "Fatebenefratelli e Oftalmico".
"Vittore Buzzi Children's Hospital is a public hospital specializing in maternal, neonatal, pediatric and adolescent medicine. As one of the largest paediatric medical centers in Milan, Children's offers a complete range of health care services for mothers and children from birth through 20 years of age.
It supports many paediatric specialties and subspecialties such as: Allergy, Anesthesiology, Cardiology, Neurology and Epilepsy Center, Critical Care Medicine, Dentistry, Dermatology, Emergency Medicine, Endocrinology/Diabetology, Gastroenterology, General Paediatrics, Genetics, Neonatology/Neonatal Intesive Care Unit, Nephrology, Neurology, Nutrition, Ophthalmology, Orthopedics-Orthopedics Surgery, Otolaryngology, Paediatric Surgery/Surgical Endoscopy, Pulmonology, Radiology, Rheumatology.
Comprehensive teaching program for doctors, nurses and medical specialists are available. Toward this goal, Buzzi Children’s Hospital has developed and maintained graduate training programs of the highest academic quality for paediatric residents and fellows as well as nurses.
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università di Milano
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, is the one of the main University hospitals in Italy. It covers research in a wide variety of medical and technical areas, with paediatric medicine that represents one of the main missions.
The Fondazione has the goal to satisfy the needs of patients through the development and evaluation of innovative diagnostic and therapeutic patterns. The high quality of research has been repeatedly recognized by visiting evaluation commissions and the Italian Ministry of Health. EU programmes represent one of the funding sources.
- Dipartimento di Salute della Donna e del Bambino–Università di Padova
ARNAS - Civico, Di Cristina, Benfratelli Palermo
The Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Civico, Di Cristina, Benfratelli (ARNAS-CDB) is the headquartered in the urban area of Palermo and provides its health services using the following hospital centers.
Civico general Hospital, with an emergency department and trauma center, operational center for territorial emergency management and all units for diagnosis and therapy in low, medium and high level of specialization; Oncology Center “Maurizio Ascoli”, with a set of multidisciplinary units for diagnosis and treatment of oncological diseases, integrated into a care-intensity framework.
The Mediterranean Institute of Paediatric Excellence (ISMEP), whose inpatient activity is organized according to the principles of care-intensity and clinical complexity and structured into the following hospitals: the “Giovanni Di Cristina” children’s hospital, with emergency area, paediatric trauma center and all units to provide multidisciplinary paediatric care of high specialization and for rare diseases; New Children’s Hospital at Fund “Malatacca” (under completion).
- Clinica di Neuropsichiatria dell’Infanzia e dell’Adolescenza Azienda Ospedaliera “G.Brotzu” di Cagliari
Università degli studi di Perugia-Dipartimento di scienze chirurgiche e Biomediche
The Department of Surgical and Biomedical Sciences at the University of Perugia unifies and coordinates the translational and clinical research activities of several biomedical research groups, including that of the Pediatric Section.
The scientific activities of the Pediatric Section are carried out in the whole Umbria Region to contribute to the knowledge of etiologic mechanisms, diagnosis, prognosis, prediction of response to therapy and design of innovative therapeutic strategies for various diseases of medical interest.
The research activities are the result of the integration of capabilities and experience of researchers and administrative staff of Umbria Region and mainly cover the areas of Infection and Immunity, Allergology, Cardiology, Cystic Fibrosis, Dermatology, Emergency Medicine, Endocrinology/Diabetology, Gastroenterology, General Paediatrics, Genetics, Metabolic Diseases, Neonatology/Neonatal Intesive Care Unit, Nephrology, Neurology, Nutrition, Oncoematology, Ophthalmology, Otolaryngology, Paediatric Surgery/Surgical Endoscopy, Pulmonology and Rheumatology.
A scientific approach is also used to foster the organization and management of health services. The high quality of research has been repeatedly recognized by visiting evaluation commissions and the Italian Ministry of Health.
- AORN "Santobono Pausilipon” - Napoli
Fondazione PENTA Onlus / PENTA‐ID
PENTA-ID Network developed in 2012 from the well-established PENTA network, originally a collaboration between paediatric HIV centres in Europe addressing relevant questions in the domain of paediatric HIV. PENTA-ID stems from the need to integrate the expertise acquired by PENTA Foundation in more than 20 years of successful activity and the need for new studies in other paediatric infectious diseases.
The network benefits from international recognition, wide geographical representativeness, very high quality research, an outstanding track record and diversified public and private funding. Its activities vary from clinical trials to cohort studies and research network development and management and training. The Fondazione PENTA ONLUS was set up in May 2004 as the PENTA coordinating centre.
The Foundation is a promoter/sponsor of clinical trials, a centre for project development and management and for the collection and dissemination of information on paediatric infectious disease related issues. It also coordinates training programmes for health providers. Since 2013 the Foundation’s headquarters have been in the Paediatric Research Institute in Padova, Italy. Since 2005 PENTA, has coordinated 7 EU funded projects (through FP6, FP7, H2020 and IMI funding programs) and participated as a partner in additional 12 EU funded projects.
The Paediatric Rheumatology INternational Trials Organisation (PRINTO) is a not for profit, non-governmental, international research network founded in 1996.
PRINTO initially included 14 European countries (over 60 countries, 550 centres worldwide with 1200 members today), with the goal to foster, facilitate and co-ordinate the development, conduct, analysis, and reporting of multi-centres, international clinical trials and/or outcome standardisation studies in children with paediatric rheumatic diseases (PRD). PRINTO coordinating centre is based in Genoa at the IRCCS Gaslini. PRINTO is composed of academic, clinical centres actively engaged in the research/clinical care of children with PRDs. PRINTO actually groups the most esteemed paediatric rheumatology researchersworldwide.
PRINTO has four main vertical structures: the Advisory Council that provides leadership and guidance for PRINTO research activities; the International Coordinating Centre whose main task is to facilitate the flow of logistic and scientific details needed to design, launch and manage multi-center, multi-national, collaborative studies; the National Coordinating Centres (one per country) whose tasks are to facilitate the participation of the greatest number possible of individual centers, and to provide the translation of all the forms to be completed by the parents/patients; the Individual Clinical Centres, that constitute the main support structure to obtain a critical mass of data for on-going and future research.
CVBF - CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a clinical research organisation, founded in 2000 with the mission to perform research and education in the pharmaceutical field integrating regulatory, clinical, epidemiological, economical and statistical expertise.
The main fields of interest are life sciences and biotechnologies, drug development for small populations (paediatric and rare diseases), research management and methodology, monitoring, statistics, regulatory, ethics and pharmacovigilance.
CVBF acts both as Sponsor or as CRO and is currently coordinating two multinational paediatric clinical research projects: DEEP – DEferiprone Evaluation in Paediatrics – FP7-Health-2010 – Grant Agreement n° 261483; GAPP – GAbapentin in Paediatric Pain – FP7-Health-2013-Innovation – Grant Agreement n° 602962
TEDDY - EUROPEAN NETWORK OF EXCELLENCE FOR PAEDIATRIC CLINICAL RESEARCH
TEDDY (European Network of Excellence for Paediatric Clinical Research) is an independent multidisciplinary and multinational research Network, composed by partners from EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research.
It was launched in 2005 as Network of Excellence (NoE) under the Sixth Framework Programme for Research and Technological Development (FP6) in response to a EU call with the aim of “structuring efforts devoted to the development of tailor made medicines for children”. Between 2005-2010, the FP6 TEDDY project played a critical role in the start-up of paediatric activities in Europe, in parallel with the introduction of the new European Paediatric Regulation.
At the end of the funding period, TEDDY has revised its organisation and has collected research centres and groups willing to be engaged in developing paediatric clinical research as requested by the new regulatory scenario. TEDDY is today a category 1 network member of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency.
A.I.E.O.P. is the Italian Association of Paediatric Haematology and Oncology. Its members are mainly paediatricians, but also haematologists, oncologists, surgeons, biologists, nurses, psychologists and all of those operators who dedicate themselves towards issues in haematology, oncology and immunology in children and adolescents. Its members have organized themselves in order to work together, while the centres which have adhered to the association, have come together to collaborate under a national network, that shares therapy protocols and research projects.
AIEOP’s main objective is to improve the care and assistance provided to children who are suffering from tumours, haematological disorders or immunodeficiencies and to promote research within this field.
One of the Association’s main objectives is to promote and foster all of those activities aimed at increasing and improving the humanization of the care provided to the haematology-oncology child and his family.
Pedianet is an independent network established in 1998 with the aim to collect epidemiological information for clinical research from family paediatricians in Italy. PEDIANET 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.
The coordination of PEDIANET projects and data analysis are carried out by a scientific committee that include paediatricians, epidemiologists and researchers.
Approximately 300 paediatricians throughout the country have taken part in Pedianet projects.
The European Child & Adolescent Psychopharmacology Network (ECAPN)is a well established network of Centres of child & adolescent psychiatry, based on several EU countries, all of whom are expert in Paediatric Psychopharmacology.
The ECAPN is supported by the European College of Neuropsychopharmacology (ECNP): its’ aims include the identification of unmet needs in child and adolescent psychopharmacology, conducting collaborative scientific studies and clinical trials, and the development of strategies to improve state-of-the-art prescribing medication to children and adolescents with psychiatric disorders in clinical practice.
SIF Società Italiana di farmacologia - Gruppo di lavoro in farmacologia pediatrica
Founded in 1939, the Italian Society of Pharmacology (SIF) was recognized in 1996 as a non-profit scientific association by the Ministry of University and Scientific and Technological Research. SIF is a member of IUPHAR (International Union of Pharmacology) and EPHAR (Federation of European Pharmacological Societies).
The current membership consists of approximately 1,200 Members.
Recently within the Society, a Working Group on Pediatric Pharmacology has been established, joined by 44 pharmacologists.
To respond to the increasing interest of individual researchers, scientific societies and pharmaceutical companies, the Pediatric Pharmacology Working Group aims to address the many specificities characterizing clinical pediatric research.
Among these: (i) the need to develop protocols designed for specific age groups, as protocols used for the adult population may be inadequate for children, as well as those for older children may be inadequate for infants and newborns;
(ii) the consolidation of competences for conducting early stage pediatric clinical trials (phase I / II, pharmacokinetic / pharmacodynamic studies) and the development of pharmacokinetic models suitable for children; (iii) the identification of biomarkers and new non-invasive parameters for drug efficacy assessment; (iv) the development of formulations suitable for children of various ages; (v) the application of innovative biostatistics methodologies; (vi) new preclinical protocols for the development of pediatric medicines and (vii) the design of studies to evaluate long-term efficacy and safety.
- IRCCS Fondazione Stella Maris