Paris – June 1st 2021
The PedCRIN (Paediatric Clinical Research Infrastructure Network) consortium will host a final event “Fostering International Paediatric Clinical Research” on June 16th 2021, from 9:30 to 13:00 CEST. The free online event will bring together stakeholders in paediatric and neonatal clinical research to discuss the key outcomes and accomplishments. PedCRIN comes to an end on June 30th 2021 and there is much to share from this project which includes direct support to clinical trials and the development of tools to facilitate clinical research in the paediatric and neonatal communities.
The PedCRIN achievement: Investigator Initiated paediatric Clinical trials
PedCRIN launched a call for trials in 2017, which provided an opportunity to promote the use of PedCRIN throughout the EU paediatric and scientific community and to engage with several paediatric and neonatal networks of academic clinical investigators interested in multinational clinical trials. The three clinical trials selected by the PedCRIN Scientific Board for PedCRIN funding were from three countries (France, Norway and Ireland) and their extension supported access to 10 European countries. The funded pilot trials have brought the opportunity to evaluate the capability to provide trial management services for multicentre neonatal and paediatric clinical trials, as well as to identify areas of improvement.
The PedCRIN achievement: tools for the empowerment of the paediatric research community
PedCRIN has developed a collection of tools and procedures to support the setup and management of multinational neonatal and paediatric trials in Europe. These tools have been developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The full collection of tools is available on the PedCRIN Website.
PedCRIN Final Event “Fostering International Paediatric Clinical Research”
The PedCRIN Final Event will include several sessions each dedicated to a different step from the setup, planning and conduct of multinational clinical trials. During this interactive meeting focused on the challenges of paediatric multinational trials, several experts in paediatric clinical research will present the main results and conclusions of the project. More specifically they will address the supporting tools, methods, identified gaps in European paediatric clinical research and future initiatives and collaborations with other existing networks, projects and institutions.
The PedCRIN coordinator, Jacques Demotes (Director General, ECRIN) will share an introduction which will be followed by a session chaired by Pirkko Lepola (Executive Secretary, FINPEDMED) to address the challenges and benefits of multinational clinical trials. Within this session, the investigator’s perspective, the sponsor’s perspective and the vision of the young person advisory groups will be shared. The next session, chaired by Saskia de Wildt (RUMC), will focus on PedCRIN’s interest in the design and setup phase of the trials and the creation of the tools for the support of paediatric and neonatal clinical trials and for patient engagement in research.
After the break, a panel discussion will take place focused on the conduct and management phase. It will address the importance of qualified resources (involvement of national networks of clinical trial units (CTUs) with feedback from CTUs involved) and operational aspects such as ethics, regulatory issues, data and more. Donato Bonifazi (CVBF) will chair the last session which will focus on the sustainability of the project and will highlight potential synergies with other existing networks and projects, such as conect4children (c4c) or the ERNs.
PedCRIN is a European project aimed at developing capacity for the management of multinational academic paediatric clinical trials. It is funded by the European Commission under grant agreement no. 731046. The PedCRIN project has involved six work packages, including the project coordination and implementation, the definition of the PedCRIN business strategy and governance structure, the development of tools specific for paediatric and neonatal trials (adverse event reporting, biosample management, ethical and regulatory database, monitoring, quality and certification), the provision of operational support to three selected trials, and communication and patients engagement in research. The PedCRIN project was an opportunity to develop a partnership with the paediatric research community and to better understand the needs of the paediatric community.
For more information on PedCRIN or the Final Event: Fostering International Paediatric Clinical Research, visit the PedCRIN website or contact PedCRIN via mail at [email protected]
PedCRIN website: http://www.pedcrin.org
Registrations for the final event: Link