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 came into force.

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



    INCIPIT and the Independent Research on drugs funded by Italian Medicines Agency – AIFA- Call 2016

    AIFA approved the final ranking of the 2016 Call for Independent Research and announced that 40 studies will be funded. Among these, two studies involve INCIPIT:

    • “PROMISE” study – Multi-center, randomized, open label pragmatic trial to compare the efficacy and safety of interferon-beta 1a (IFN-beta 1a) weekly i.m. and glatiramer-acetate (GA) in pediatric patients affected by multiple sclerosis – proposed by Prof. Lucia Margari of the University of Bari ‘Aldo Moro’ – Bari University Hospital.
    • “Comparison of STep-Up and step-Down therapeutic strategies in Childhood Arthritis” proposed by Dott. Alessandro Consolaro and Professor Angelo Ravelli of the Institute Giannina Gaslini- Genova.

    In the framework of the these projects, INCIPIT will offer several services such as : Identification of possible additional centres to meet the recruitment plan, Support for Ethics approval and Competent Authority authorization, prepare the monitoring plan and perform monitoring activities.



    Many initiatives in Europe are promoting the creation and implementation of Paediatric Clinical Trials Centres Networks and Infrastructures.

    The TEDDY Network (European Network of Excellence for Paediatric Clinical Research), in collaboration with INCiPiT, has developed a survey aimed to collect expertise of centres performing paediatric clinical trials, available services, equipment and cross-competences related to paediatric clinical research.

    In order to assess these services and expertise of Centers participating or interested to be associated INCiPiT, we invited all the partners to participate in the survey.

    The questionnaire was agreed with EnprEMA (European Network of Paediatric Research at the European Medicines Agency) and other networks participating to EnprEMA, and particularly with FINPEDMED (the Finnish Investigators Network for Paediatric Medicines).

    We are going to publish very soon the overall results.

    In the private area you can find the partial results gained so far.

    Thank you for the collaboration!