PROVIDE METHODOLOGICAL, ETHICAL AND REGULATORY SUPPORT TO THE RESEARCH

RESEARCH METHODOLOGY

Elaborating and revising guidelines and recommendations, implementing innovative studies' designs and research methods (especially for rare and paediatrics diseases), planning and performing observational studies and registries, are some of the applications of the Gianni Benzi Foundation methodological expertise.

The Foundation also works on the HTA (Health Technology Assessment) field, to evaluate both real and potential effects of technology, as well as the consequences that the introduction or the exclusion of an intervention (for example a medicine or a device) has for the health system, the economy and society. Furthermore, the Foundation carries out pharmacoeconomic studies and analysis on the use of drugs and other health technologies aimed at providing summaries and evaluations of the available evidence, including the PROs (Patient Reported Outcomes) and Quality of life (QoL) assessment.

RESEARCH PROJECTS

Fondazione Gianni Benzi participates in many national and international projects where it is in charge of providing scientific expertise as well as regulatory, ethical and methodological support. In particular, we contribute to the planning and conduct of interventional and non-interventional clinical studies (methodology, design, compliance with ethical and regulatory requirements, data collection and analysis), project management, IT tools set up (platforms, database, e-learning instruments, survey), providing contents to dissemination and education activities.

c4c - COllaborative Network for European Clinical Trials For Children

Better medicines for babies, children and young people through a pan-European clinical trial network

The project is setting up a large collaborative paediatric network that will facilitate the development of new drugs and other therapies for the entire paediatric population in Europe. the consortium works to build capacity for the implementation of multinational paediatric clinical trials whilst ensuring the needs of babies, children, young people and their families are met. c4c strives to bring innovative processes to all stages of clinical development by generating a new model of organization and of the clinical development process. By emphasizing inclusiveness and collaboration across geographical, specialty, sectoral, cultural and societal backgrounds, it will set up a new infrastructure to support all evaluations of medicines in children.

ROLE OF THE FOUNDATION
The Foundation is partner of the project co-leading the activities related to “data coordinating centre and data quality standards”, specifically contributing to implementing performance metrics in execution of Paediatric Clinical Trials. Other activities are carried out for preparing training course and material and dissemination campaignes to increase awareness on paediatric research.

http://conect4children.org/ - c4c (CORDIS)

FUNDED BY: H2020
DURATION: may 2018 >
PARTNERS:43
COUNTRIES INVOLVED
Italy, UK, The Netherlands, Denmark, Switzerland, Portugal, Belgium, Estonia, Austria, Germany, Greece, Poland, Norway, Ireland, Sweden, Spain, Hungary, France, Czech Republic, USA

European Paediatric Translational Research Infrastructure

Translational infrastrucure to enhance paediatric research and foster innovation

The main objective of this project is to create design the framework for the European Paediatric Translational Research Infrastructure (EPTRI), a new Research Infrastructure (RI) aimed to enhance technology-driven paediatric research in discovery and early development phases to be translated into clinical research and paediatric use of medicines.

ROLE OF THE FOUNDATION
The Foundation is a third party of CVBF. Its main responsibility is designing the organisational and technical model of the infrastructure, providing the setting-up and implementation of IT platform and IT technologies to coordinate the information flow (communication, collaboration, and information sharing) among the participating units and services within the research infrastructure and with the external environment (member states, industry, patients and other research groups).

https://eptri.eu - EPTRI (CORDIS)

FUNDED BY: H2020
DURATION: Jan 2018 >
PARTNERS:26
COUNTRIES INVOLVED
Italy, The Netherlands, UK, Greece, Austria, Cyprus, France, Romania, Poland, Czech Republic, Portugal, Russia, Spain, Albania, Israel, Estonia, Germany, Switzerland, Sweden

Paediatric Clinical Research Infrastructure Network

Develop capacity for the management of multinational paediatric non-commercial clinical trials

The project is aimed to create a paediatric research infrastructure starting from ECRIN infrastructure and including 14 partners involved in paediatric clinical research. PedCRIN represents a valid implementation step covering the issue of managing good paediatric trials.

ROLE OF THE FOUNDATION
The Foundation provides resources to CVBF with the aim to make available expertise to develop and adapt tools to be used for multinational paediatric clinical trials. Also, it provides for the training and support of partners on the use of these tools.

www.ecrin.org/projects/pedcrin - PedCRIN (CORDIS)

FUNDED BY: H2020
DURATION: Jan 2017 >
PARTNERS:15
COUNTRIES INVOLVED
France, UK, Italy, the Netherlands, Finland, Spain, Switzerland, Sweden, Norway, Estonia, Greece, Austria, Ireland

Early treated Perinatally HIV Infected individuals: Improving Children’s Actual Life

Predictive platform for the early identification of novel therapeutic strategies for HIV infected children

The project is aimed to establish predictive in vitro and in vivo platform to select promising HIV therapeutic vaccine candidates and to evaluate a therapeutic vaccine strategy to improve the management of perinital HIV-Infected children.

ROLE OF THE FOUNDATION
The Foundation provides resources to CVBF with the aim to make available expertise to coordinate all ethical and regulatory activities related with clinical studies and health data collection and sharing.

www.epiical.org

FUNDED BY: Fondazione PENTA Onlus
DURATION: Feb 2016 >
PARTNERS:27
COUNTRIES INVOLVED
Italy, UK, France, Spain, Sweden, USA, South Africa, The Netherlands, Thailand, Canada, Mozambique

Small Medicines Advanced Research Training

Improvement of the Children’s Memorial Health Institute staff’s research profile and increase capacity in providing innovative paediatric research methods

The twinning project is aimed to raise the Children’s Memorial Health Institute (IPCZD, Warsaw) staff’s research profile and increase capacity in providing innovative paediatric research methods such as PK-PD data Modelling&Simulation (M&S) data extrapolation, and suitable dosage forms identification.

ROLE OF THE FOUNDATION
The Foundation provides resources to CVBF with the aim to make available expertise to coordinate the training program including face-to-face, e-learning and staff-exchanges to provide competences and skills in the 4 research profiles according to students preferences and plan of activities.

http://www.smart-h2020.eu - SMART (CORDIS)

FUNDED BY:H2020
DURATION: Jan 2016 > Dec 2018
PARTNERS:3
COUNTRIES INVOLVED
Poland, Italy, UK

Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

Studying clonidine for sedation in paediatric and neonatal intensive care units

Conduction of a multicentre clinical trial of clonidine in children until the age of 18. Indeed, despite its widespread use in Pediatric Intensive Care Units (PICU), this drug still lacks authorisation for paediatric use. A parenteral age-appropriate formulation of clonidine for sedation in PICU will be developed and tested in order to obtain a Pediatric Use Marketing Authorisation (PUMA).

ROLE OF THE FOUNDATION
The Foundation is partner of the project as involved in regulatory and ethical issues and coordinates the dissemination activities. It also supports the project management.

www.closed-fp7.eu - CloSED (CORDIS)

FUNDED BY:FP7
DURATION: Dec 2013 > Nov 2018
PARTNERS:10
COUNTRIES INVOLVED
Germany, UK, The Netherlands, Italy, Sweden, Czech Republic, Estonia, Spain

Gabapentin in paediatric Pain

Providing children with a safe and effective medication for chronic pain

The project is aimed to study and expand the availability of drugs for children in chronic pain through the development of a gabapentin formulation appropriate for them.

ROLE OF THE FOUNDATION
The Foundation supports the ethical and regulatory activities related to the clinical studies and coordinates the project Ethics Boards.

www.pediatricpain.eu - GAPP (CORDIS)

FUNDED BY:FP7
DURATION: Jul 2013 >
PARTNERS:15
COUNTRIES INVOLVED
Italy, The Netherlands, Estonia, UK, Germany, Albania, France, Spain, Greece

Inherited NeuRoMetabolic Diseases Information NETWORK

Information Network and IT Platform on Inherited NeuroMetabolic Diseases

The project aims to increase the current knowledge on iNMDs (Inherited NeuroMetabolic Diseases), speed up the timely and precise identification of patients, who thus may benefit from the available (experimental and marketed) treatments, and also favour biomedical research. The Platform also acts to connect the Network nodes, to stimulate collaborative working and to promote the networking activities.

ROLE OF THE FOUNDATION
As a project partner, the Foundation was involved in the project management and in the development of the IT platform used to collect, share and store the information on Inherited NeuroMetabolic Diseases (iNMDs) and in the preparation of ethical and methodological recommendations to favor biomedical research.

www.innermed.eu

FUNDED BY:EU Health Programme
DURATION: Apr 2013 > May 2016
PARTNERS:5
COUNTRIES INVOLVED
Italy, Spain, Denmark, Croatia

Verso la Medicina Personalizzata: Sviluppo di nuove molecole selettive per la cura del Neuroblastoma

Small biologically active molecules for the diagnosis and the treatment of neuroblastoma

The project is aimed to develop small biologically active molecules for the diagnosis and the treatment of neuroblastoma.

ROLE OF THE FOUNDATION
The Foundation was the project partner in charge of the identification of the existing educational and training programmes and in the preparation of the educational material of the Module of the Master related to paediatric clinical trials methodology, including privacy and data protection.

FUNDED BY:Fondazione CON IL SUD
DURATION: Oct 2012 > Nov 2015
PARTNERS:5
COUNTRIES INVOLVED
Italy, Ireland

Global Research in Paediatrics

EU network of excellence to stimulate and facilitate the development and safe use of medicines in children

GRIP, the Global Network of Excellence is aimed to implement an infrastructure to stimulate and facilitate the development and the safe use of medicines for the paediatric population. Its main outcome is the creation of the Master of Science in Paediatric Medicines Development and Evaluation.

ROLE OF THE FOUNDATION
The Foundation provides resources to CVBF with the aim to make available regulatory, ethical and pharmacoeconomic expertise. The Foundation was also involved in the project management and training activities.

www.grip-network.org/index.php/cms/en/home - GRIP (CORDIS)

FUNDED BY:FP7
DURATION: Jan 2011 >
PARTNERS:21
COUNTRIES INVOLVED
Italy, USA, The Netherlands, UK, France, Spain, Poland, Finland, Canada

Deferiprone Evaluation in Paediatrics

Providing children affected by thalassaemia and other transfusion-dependent haemoglobinopathies with a new formulation of deferiprone

The project is aimed to study the efficacy and safety of deferiprone in children affected by β-thalassaemia major and other transfusion-dependent haemoglobinopathies.

ROLE OF THE FOUNDATION
The Foundation supported of the ethical and regulatory activities.

www.deepproject.eu/ - DEEP (CORDIS)

FUNDED BY:FP7
DURATION: Jan 2011 > Aug 2016
PARTNERS:16
COUNTRIES INVOLVED
Italy, the Netherlands, Greece, Albania, Cyprus, Egypt, Canada, Germany, Tunisia

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