Objectives and results
The general objective of the GRiP project is to facilitate the development, and promote the availability, of medicines for children.
This will be achieved by reducing the fragmentation of on-going efforts in relevant fields of research.
In addition, GRiP aims to create consensus on international standards, methodologies and tools for paediatric research. The day-to-day work of the GRiP consortium will primarily focus on:
The work of GRiP has been divided into nine Work Packages, each dealing with a fundamental aspect of the development of medicines for children. This website provides all the information on the day to day work of each work group, including all the deliverables foreseen under each work package. To obtain more detailed information on GRiP activities, click on the items from the list of work packages below. You will be able to download papers, abstracts, presentations and other documents produced by GRiP members in their effort to develop knowledge in paediatric clinical pharmacology.
For an up-to-date summary of all the deliverables that have been submitted so far, please visit the Results Summary page.
Training and Education (WP1)
|Tools for interoperability (WP3)|
|Paediatric clinical studies (WP4)||Paediatric formulations (WP5)||Drug development in neonates (WP6)|
Management and Communication (WP7, 8 and 9)
By achieving the tasks planned under each work package, GRiP Project members aim to reach the following objectives:
1. Internationally recognised paediatric clinical pharmacology training program
GRiP aims to increase the number of internationally trained paediatric clinical pharmacologists, researchers and formulation scientists by developing an internationally recognised paediatric clinical pharmacology training program. GRiP will aim to prepare experts in paediatric clinical pharmacology able to work both at regulatory and clinical research level. The program will be co-ordinated by experienced educators from Europe, North America and Japan, delivered by a broad range of experts using a diverse and well-adapted palette of educational interventions and carried out in collaboration with relevant International stakeholders (International Union of Basic and Clinical Pharmacology – IUPHAR, WHO, Pharmaceutical Industries Associations, ESDP etc) and academic and scientific Institutions.
2. Integrated electronic infrastructure
GRiP aims to develop an integrated electronic infrastructure for epidemiological, pharmacovigilance and post marketing research.
This infrastructure will exploit and link existing healthcare databases in Europe and the US to assess the occurrence of diseases in children, plus the use and effects of drugs (including vaccines) on a large scale. Methodologies for harmonization, data exchange across national boundaries (including ethical and governance issues), data mining and comparative safety and effectiveness studies will be developed.
GRiP aims to develop paediatric research tools to facilitate interoperability in paediatric research which will improve efficiency in clinical research and enable comparison of study results. This will include harmonisation of terminology and data standards for paediatrics across the Atlantic and Japan and identification, development and harmonisation of outcome measures, endpoints and biomarkers to evaluate paediatrics drug responses.
4. Information sharing
To develop and evaluate models for information sharing for Human Research Subject Protection among ethics committees and Institutional Review Boards to facilitate review and support consistency in review practice.
5. New types of clinical trials in children
To explore and validate the use of new protocol designs, procedures and methodologies for clinical trials in children. Alternative approaches to standard clinical protocols will be evaluated to study drug efficacy and safety in neonates, infants and other small populations (e.g. rare disease).
6. International platform for paediatric drug formulation
To create and maintain an international platform to share knowledge and educate professionals on paediatric drug formulation to support clinical trials worldwide; particular attention will be given to the needs of children under 5 years.
7. International initiative for clinical trials in neonates
To set up an international initiative for implementation of clinical trials in neonates. This will include an establishment of effective links with North American and other European networks.
8. Expansion of network activities
To create a durable collaboration between participating partners and expand network activities to other countries and settings including low income countries.
9. Knowledge translation, exploitation and mobilisation
To base dissemination and implementation of GRiP outputs on well-planned activities relating to knowledge translation, exploitation and mobilisation.