Global Research in Paediatrics
Paediatric drugs (PD) lack appropriate testing. Most drugs have inadequate information about dosing regimen, dose adjustment and how to administer them. These are longstanding problems that unquestionably require concerted efforts at the international level. Both the US and the EU have introduced paediatric legislation that facilitates participation of children in research and pharmaceutical innovation but initiatives are not always coordinated and often different approaches are used to deal with the same problems. The main aim of GRIP will be to implement an infrastructure matrix to stimulate and facilitate the development and safe use of medicine in children. This implementation entails active coordination of knowledge management efforts and integrated use of existing research capacity, whilst reducing the fragmentation and duplication of activities.
The consortium will primarily focus on:
1) development of a Paediatric Clinical Pharmacology Training Program;
2) Validation and harmonisation of research tools specific for paediatrics;
3) Sharing of strategies and plans;
4) Use of ongoing/planned research studies to evaluate the feasibility of proposed research tools and strategies.
GRIP brings together an exceptional range of high quality leaders and stakeholders that are very active in the context of EU and US paediatric medicines research. GRIP will mobilize 21 institutions as partners and at least another 16 major networks that represent several hundreds of clinical sites and a total of more than 1000 researchers across Europe, the US and Asia. The integration of the WHO, EMA and the NIH-NICHD associated networks, including the FDA, will be a major asset not just for an effective implementation of the network activities without duplication, but also for the rapid translation of GRIP deliverables into practice. This partnership will work closely with families to provide children with safe and effective medicines.
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administrative contact: Steven HIRSCHFELD (Dr)
Independence Avenue S. W. 200, WASHINGTON D.C., UNITED STATES
AZIENDA OSPEDALIERA DI PADOVA
Administrative contact: Antonio GIONA (Dr)
Via Giustiniani 1, PADOVA, ITALIA