The lack of availability of appropriate medicines for children is an extensive and well-known problem.
Off label or unlicensed administration of medicinal products in every day paediatric practice is still frequent. It is very important that all medicines intended for children are appropriately studied in paediatric populations in addition to adults.
The barriers to proper research on children’s drug development include several complex factors, such as the limited commercial interest, lack of suitable infrastructure and competence for conducting paediatric clinical trials, difficulties in trial design, ethical worries and many others.
This lack of knowledge has been acknowledged by EU and US lawmakers and for that reason, specific regulations are in place to stimulate drug studies in children. In 2007, the Paediatric Regulation (EU 1901/2006
This regulation includes a requirement that the pharmaceutical industry conducts clinical trials with medicinal products also on children if the European Medicines Agency (EMA) judges that the medicine is essential and needed in the treatment of pediatric diseases.
Nevertheless, due to the historical neglect to study drugs in children, both academia and industry, are less experienced and organized to conduct these studies, when compared to the adult world. As a consequence there is a high need for both expertise and logistic support to conduct pediatric drug trials successfully.
The scope of INciPiT is to foster high-quality research on drugs in children in Italy; INCiPiT aims to support the planning, conduction and completion of all types of clinical studies in the paediatric population, by providing expertise and coordinating logistical support to academic investigators as well as to pharmaceutical industries and contract research organisations.
INCiPiT members include the main Italian Paediatric Hospitals and Scientific Institutes for Research, Hospitalization and Health Care (IRCCS) and other Institutions, which operate at different level in paediatric research. Actually, INCiPiT counts for 21 Partners.
The main tasks of INCiPiT are:
- improve opportunities for performing pediatric clinical trials in Italy
- provide training and create competences
- harmonize joint national operational models
- create guidelines and templates to help serve research
- provide effective and timely communication among INCiPiT Members
- involve children and young people and their families in paediatric research