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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

http://www.unipg.it

http://www.scb.unipg.it/

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.

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.

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

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.

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.

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 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.

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.