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EU research results

CORDIS

Global Research in Paediatrics

Fact Sheet

Result in Brief

Reporting

Results

Objective

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.

Field of Science

paediatrics

Programme(s)

FP7-HEALTH - Specific Programme "Cooperation": Health

Topic(s)

HEALTH.2010.4.2-2 - International Paediatric initiative. FP7-HEALTH-2010-single-stage

Call for proposal

FP7-HEALTH-2010-single-stage

See other projects for this call

Funding Scheme

NoE - Network of Excellence

Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

AZIENDA OSPEDALIERA DI PADOVA

Address

Via Giustiniani 1
35128 Padova

Italy

Activity type

Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)

EU Contribution

€ 335 297,75

Website

Contact the organisation

Administrative Contact

Carlo Giaquinto (Prof.)

Participants (22)

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THE SCHOOL OF PHARMACY, UNIVERSITY OF LONDON

United Kingdom

United States Department of Health and Human Services

United States

THE EUROPEAN MEDICINES AGENCY

United Kingdom

EU Contribution

€ 150 900

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 1 135 134

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 725 688

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 721 932

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 558 941,82

National Center for Child Health and Development

Japan

EU Contribution

€ 83 642

ST GEORGE'S HOSPITAL MEDICAL SCHOOL

United Kingdom

EU Contribution

€ 314 332

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE

Italy

EU Contribution

€ 1 057 721,25

UNIVERSITEIT LEIDEN

Netherlands

EU Contribution

€ 222 169,98

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM

Netherlands

EU Contribution

€ 235 288

FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS

Spain

EU Contribution

€ 408 304,63

INSTYTUT POMNIK CENTRUM ZDROWIA DZIECKA

Poland

EU Contribution

€ 145 601,94

WORLD HEALTH ORGANIZATION

Switzerland

EU Contribution

€ 99 357

UNIVERSITY COLLEGE LONDON

United Kingdom

EU Contribution

€ 586 728,88

HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ

Finland

EU Contribution

€ 788 560

BRIGHTON COLLABORATION FOUNDATION

Switzerland

EU Contribution

€ 602 997

FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS

Italy

EU Contribution

€ 1 022 792

VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES

Netherlands

EU Contribution

€ 123 750

The Hospital for Sick Children

Canada

EU Contribution

€ 578 100,01

UNIVERSITE PARIS DIDEROT - PARIS 7

France

EU Contribution

€ 102 761,53

Project information

GRIP

Grant agreement ID: 261060

Status

Closed project

Start date

1 January 2011
End date

30 June 2017

Funded under:

FP7-HEALTH

Overall budget:

€ 12 637 322,83
EU contribution

€ 9 999 999,79

Coordinated by:

AZIENDA OSPEDALIERA DI PADOVA

Italy

DE EN ES FR IT PL

Study and development of safe and effective medicines for children

The majority of drugs used in the paediatric population are not tested for children. With most drugs having inadequate information about dosing regimen, dose adjustment and administration and safety in this group, the EU-funded GRiP initiative integrated global efforts towards standard practice.

HEALTH

Randomised controlled trials (RCTs) are considered the gold standard for assessing the efficacy of drugs prior to their approval for use in the general population. In children, physiological characteristics such as growth and hormonal status are different from adults and have impact on both pharmacokinetics and pharmacodynamics. Separate evaluation is required including adverse side effects for the different paediatric age groups, e.g. neonates. More than 1 000 researchers take part in the integrated initiative To address these issues, the EU-funded GRiP project mobilised 22 institutions from Europe, North America and Japan, as well as the WHO. The key objective was to generate a Network of Excellence and provide the necessary infrastructure and knowledge for drug evaluation and development in the paediatric population. One significant result is an internationally recognised educational programme to improve training for young researchers in paediatric medicine. Hosted by the University of Rome, the only MSc course of its kind, it has acted as a pilot programme for the development of a Joint Degree MSc programme. Safe, evidence-based drug development ‘Children are a special population and there are major medical, scientific, practical and ethical issues in relation to the investigation of drug effects,’ explains GRiP coordinator, Prof. Giaquinto. In addition, when RCTs are not possible, there should be appropriate methodologies and adapted designs in place that can evaluate the efficacy of drugs in children and, in particular, neonates. The integrated network also shared expertise as well as standards and procedures supporting paediatric medicine development and evaluation. As with many scientific fields, clinical research in paediatric drug development and testing is fragmented. To support interoperability, all developed tools can be used globally to evaluate paediatric drug responses. Reports and guidance were provided to enhance the quality and impact of paediatric drug trials with a focus on collaboration. Additional approaches promoting modern research standards such as modelling and simulation tools, extrapolation, as well as input from patients and families were organised to facilitate high-quality clinical drug development in children. This allowed harmonisation in several activities, e.g. protocol implementation, data collection and analysis on a global scale. Furthermore, these strategies could reduce the number of children enrolled in trials supporting the use of bridging methodologies for regulatory procedures. Towards improved paediatric clinical research Researchers addressed specific issues for paediatrics covering data capture and use, practical and evidence-based guidance to enhance the quality of trials, innovative study designs and drug formulation. These included identification of biomarkers and new trial methods. For neonates, special considerations included neonatal specificities for drug development, protocols and strategies in neonatal diseases, an inventory of neonatal centres involved in research as well as maternal issues. Online, a platform for data sharing of epidemiological and observational studies and healthcare databases also facilitated the detection of safety signals of interest for children. Specifically for formulation, on the GRiP website, a webpage providing online and offline resources for excipients, inert drug binders, and contact details of international formulation experts. The page also includes a "meet the expert" section where users can access free webinars on formulations. ‘The potential impact of GRiP will be to transform paediatric clinical research from a fragmented under-funded enterprise into a concerted activity by leveraging the resources, talent, knowledge and dedication of the partners,’ envisages Giaquinto. An important aspect of the project was the collaboration of regulatory bodies, research groups and industry, cooperation that will undoubtedly become ‘standard practice’.

Keywords

GRiP, children, medicines, paediatric formulation, infrastructure, clinical studies methodologies, training

Project information

GRIP

Grant agreement ID: 261060

Status

Closed project

Start date

1 January 2011
End date

30 June 2017

Funded under:

FP7-HEALTH

Overall budget:

€ 12 637 322,83
EU contribution

€ 9 999 999,79

Coordinated by:

AZIENDA OSPEDALIERA DI PADOVA

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Project information

GRIP

Grant agreement ID: 261060

Status

Closed project

Start date

1 January 2011
End date

30 June 2017

Funded under:

FP7-HEALTH

Overall budget:

€ 12 637 322,83
EU contribution

€ 9 999 999,79

Coordinated by:

AZIENDA OSPEDALIERA DI PADOVA

Project information

GRIP

Grant agreement ID: 261060

Status

Closed project

Start date

1 January 2011
End date

30 June 2017

Funded under:

FP7-HEALTH

Overall budget:

€ 12 637 322,83
EU contribution

€ 9 999 999,79

Coordinated by:

AZIENDA OSPEDALIERA DI PADOVA

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Last update: 1 August 2019

Record number: 97619

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Participants (22)

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Study and development of safe and effective medicines for children

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Objective

Coordinator

Participants (22)

Project information

Study and development of safe and effective medicines for children

Keywords

Project information

Discover other articles in the same domain of application

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Deliverables

Publications

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