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FP7

GRIP Report Summary

Project ID: 261060
Funded under: FP7-HEALTH
Country: Italy

Periodic Report Summary 4 - GRIP (Global Research in Paediatrics)

Project Context and Objectives:
Global Research in Paediatrics - Network of Excellence (GRiP) is an EU-funded project (FP7/2007-2013, ECGA HEALTH-F5-2010-261060) which aims to stimulate and facilitate the development and safe use of medicine in children. It started on 1 Jan. 2011 and is expected to last until 31 Dec. 2015.

The main reason for the existence of GRiP is the lack of appropriate testing of paediatric drugs, with most drugs having inadequate information about dosing regimen, dose adjustment and administration.
GRiP partners are working to build and maintain an infrastructure matrix, which aims to reduce the current fragmentation of the efforts of to study, develop and use medicine in children. GRiP is mobilising 21 institutions from Europe, North America and Japan, as well as the WHO. By linking the existing paediatric research networks, GRiP will involve more than 1,000 institutions worldwide.

The main characteristic of GRiP, as a project for the improvement of paediatric health, is that GRiP is data driven and the data and evidence provide the basis, authority and responsibility to our efforts. The basis is the scientific method, the authority is based on the principle of data driven and evidence based and the responsibility is that we have the obligation to share the data to advance the field:
1. GRiP is transparent through a state of the art consensus driven process that by intent is inclusive of stakeholders;
2. GRiP is relevant because it is dedicated to developing tools and methods to catalyse research, improve and sustain quality, lower costs and harmonize training and practice;
3. GRiP, through the mission and process, can begin to reach out to specific future partners such as the pharmaceutical industry, funding organizations, patient and advocate organizations and regulators on a flow basis as deliverables are completed;
4. GRiP priorities are to coordinate the completion of deliverables, affirm the utility of deliverables and develop sustainable models to maintain the utility and relevance of the Work Package products.

Education and training is the largest GRiP WP and central to the Network’s activities. The aim is to disseminate good practice by developing education and training that is suitable for a range of audiences, including researchers, families, children and young people. Other Work Packages examine clinical trials, formulations, neonates and the best way for studies to work together. Each Work Package has been developed by internationally recognised experts in their fields and will be implemented across Europe and the USA. Work in Japan and other countries ensures that the outputs are relevant to a global audience. The WHO facilitates contacts in low-income countries.

GRiP is divided in 9 Work Packages (WP), which are the pillars of the network’s work plan:
1.JOINT PAEDIATRIC CLINICAL PHARMACOLOGY INTERNATIONAL TRAINING PROGRAM: establishing an internationally recognized educational program in paediatric clinical pharmacology;
2.INTEGRATED INFRASTRUCTURE FOR PAEDIATRIC EPIDEMIOLOGICAL AND POST MARKETING DRUG STUDIES: to facilitate paediatric drug and vaccine development by innovative approaches, standardized methodologies and better utilization of existing healthcare databases;
3.RESEARCH TOOLS TO FACILITATE INTEROPERABILITY IN PAEDIATRIC RESEARCH: to study the current existing methodologies used for paediatric clinical research;
4.NEW METHODS FOR CLINICAL STUDIES IN PAEDIATRICS: to assess, develop and improve innovative approaches for paediatric clinical research;
5.PAEDIATRIC FORMULATIONS: to create a platform for sharing expertise and support training in paediatric formulations;
6.DRUG DEVELOPMENT IN NEONATES: to organize the international consensus on high-quality clinical drug development in neonates;
WP7 - DISSEMINATION AND NETWORKING: to ensure all the communication and networking needs of GRiP are met;
WP8 - SCIENTIFIC COORDINATION: to ensure effective coordination of all scientific activities of GRiP;
WP9 - PROJECT MANAGEMENT.

Project Results:
All the beneficiaries, and their 3rd parties, are working according to the work plan as stated in the ECGA; the work performed since the beginning of the project and the main results achieved so far are:
- WP1: an international joint master and an exchange programmes have been developed with 3 Universities hosting the Master (Rome-Tor Vergata, Paris-Diderot and Erasmus-Rotterdam) started as a pilot in 2014. A first curriculum for a specialisation program “Fellowship in Paediatric Clinical Pharmacology” has been prepared. A virtual Learning Environment is online. The GRiP Roadshow has already been delivered to about 1,100 participants in 15 events in Europe, India and Australia.
- WP2: a research environment for data sharing of epidemiological studies has been implemented as an online platform for scientific collaboration resembling that of a single “virtual” research institution. Health care databases and data sources have been descripted. A first report on International Adverse Drug Event databases has been realised. A common data model for spontaneous reporting databases is available: FAERS, VAERS, WHO, EUDRAVIGILANCE, a protocol and statistical analysis plan for the creation and testing for new methods, and a reference set of positive and negative drug- and vaccine-event associations. These reference sets can be used to verify whether they can identify paediatric specific signals.
- WP3: several initiatives in the field of practical and evidence-based guidance to enhance the quality and impact of paediatric drug trials with a focus on collaboration and interoperability have been developed. A comprehensive approach to the development, harmonization, and promotion of modern research standards has been developed and is currently being executed. Members have further collaborated particularly with regard to exchange of information with Ethics committees, terminology, biomarkers, analysis of comparators, and facilitating patient and family input into clinical trial designs
- WP4: several publications and other tools on modelling and simulation, innovative design, data extrapolation, sample size, and comparators to support paediatric drug developmental strategies have been made available. Case studies on epilepsy are in an advanced stage (validation) and others in different therapeutic areas are being initiated. Dialogue with Extrapolation WG at EMA could provide advantages in reaching a common consensus among interested stakeholders.
- WP5: a GRiP paediatric formulation webpage is online. The training content and format of on-line training modules on paediatric pharmacology/pharmacy and paediatric formulation has been developed. An inventory of experts on paediatric formulations is continuously on-going (more than 60 experts). 13 webinar sessions have taken place since autumn 2012 and continue on a quarterly basis with a range of global participants (mean 98) from clinical, regulatory and industry backgrounds. The STEP (Safety and Toxicity of Excipients for Paediatrics) database - a user designed resource that compiles data of excipients (now 40) scattered over various sources and presents them in one freely accessible source – is under continuous development in collaboration with the US-EU PFI initiative.
- WP6: a report on existing neonatal networks outside EU has been realised. An inventory of protocols and strategies in neonatal diseases has been prepared in collaboration with ESNEE (European Study for Neonatal Excipient Exposure). A Delphi process is finalized to optimize quality and performance of drug evaluation in neonates. A report to identify difficulties to perform clinical trials in pregnant women is in preparation.
- WP7: the continuously updated project website is online, including a newsletter service (http://grip-network.org/index.php/news/newsletter). To facilitate engagement by patients, interested representatives from EU or international organisations can participate in the “call for patient organizations” through the GRiP website.

Potential Impact:
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 to accomplish the stated objectives. GRiP will have a catalyst effect on relevant research activities and thereby enable closer integration of programmes in EU and non-EU regions to the extent that such integration will become standard practice. This will also lead to the accelerated availability of medicinal products with sufficient information for children.
Research efforts will be integrated through attention to standards and interoperability to leverage resources and enhance meta-analyses. The standards will encompass terminology, data acquisition, transcription and common definitions of biomarkers, clinical measures, and outcomes. Specific deliverables in trial methodology, ethics, clinical pharmacology (modelling & simulation), pharmaco-epidemiology, new formulations and drug and vaccine safety will have direct implications on the design, implementation and analysis of CTs. Together, these efforts will create an unprecedented platform, facilitating the evaluation and development of medicines for children.
GRiP will increase the number of trained paediatric clinical pharmacologists, researchers and formulation scientists by developing an internationally recognised paediatric clinical pharmacology training program that will prepare experts with competencies to support effective implementation of clinical research protocols and enable regulatory review. The program will be carried out in collaboration with relevant international stakeholders to ensure concerted effort and harmonisation.
An integrated electronic infrastructure for epidemiological, pharmacovigilance and post marketing research in paediatric drug and vaccine will be developed including databases from Europe and the US. This will improve the power and efficiency of the pharmacovigilance activities that are critical to assure safe and proper use of medicines and vaccines in paediatrics.
Furthermore the validation and standardisation of paediatric specific research tools will facilitate interoperability in paediatric research. This will lead to improved efficiency in running CTs and a greatly enhanced capacity to compare and integrate study results. Common definitions and biomarker use will improve quality and decrease costs for paediatric research. Alternative approaches to current practice in clinical investigations and protocol design will also be explored and validated.
The collaborations with relevant international partnerships will promote a shared view on how to overcome feasibility issues in paediatric formulations. A big impact will be seen in the SMEs which will be empowered to develop new paediatric formulations for PUMA. We expect the activities carried out in GRiP to have long-lasting effects in improving the capability and capacity of both industry and the scientific community in paediatric medicines research and development.
Liaison with the EuPFi, WHO, EMA and NIH will avoid duplication of activities related to excipients for paediatric medicines and maintain up-to-date information in this field.
Neonates are a special population and there are major medical, scientific, practical and ethical issues in relation to the investigation of drug effects in in-term and preterm neonates. These issues will be addressed bringing together regulatory bodies, research groups and industries to agree on common policies and develop long term actions and specific tools (e.g. standards for clinical, PK and pharmacogenomics studies) which a major impact in the evaluation of drugs in neonatology settings.
Partnerships with the EMA, WHO and NICHD-NIH and affiliated partners, including FDA, ensure that the needs of the key stakeholders in the area are always adequately considered.

List of Websites:
http://www.grip-network.org

Reported by

AZIENDA OSPEDALIERA DI PADOVA
Italy
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