The PedCRIN project is coming to a close and we would like to go out big! For this reason, we are launching a webinar series to share some of the most interesting outcomes of the project. The series will be completed by the PedCRIN Final Meeting that will be an open meeting. In the webinars, we will present the tools for the setup and management of paediatric and neonatal clinical trials that have been developed through PedCRIN. The ultimate objective of this collection of resources is to speed up and facilitate the execution of clinical trials for neonates, children and young people.
CVBF and INSERM will explain the methodology employed in the development process of the tools, as well as, the relevance of the tools for researchers and clinicians.
In the second webinar, representatives from VSOP and FSJD, the partners involved in communication, dissemination and patient engagement, will host a session addressed to researchers who are interested in including an effective patient involvement strategy in their studies.These webinars are addressed to researchers and medical professionals interested in conducting paediatric clinical research but are also open to patient associations, patient advocates and expert patients.
- Tools for the management of paediatric trials: handling biosamples and assessing causality of adverse events | April 7th 2021 (13:00 -14:00 CEST)
- Methods for the engagement of youth and families in paediatric clinical trials - Towards patient-centred studies | April 28th 2021 (13:00 -14:00 CEST)
- Practical points to consider for neonatal trials - An introduction to the PedCRIN neonatal tools | May 19th 2021 (13:00 -14:00 CEST)
Our first webinar is dedicated to the tools for managing paediatric trials. The speakers are Viviana Giannuzzi from FGB (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus) and Cristina Manfredi from CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche).
Managing paediatric clinical trials is a challenging endeavour due to the intrinsic characteristics of the paediatric population: the limited number of eligible patients, the differences in pharmacokinetics and pharmacodynamics between children and adults and also among children of different ages, the need for implementing ad hoc study procedures, the ethical considerations and the general perception that paediatric patients are vulnerable study subjects all unite to raise the complexity of clinical studies.
PedCRIN developed and/or adapted existing tools to be used for the setup and management of these studies. This webinar will present two different instruments:
- A checklist developed to help researchers, sponsors and other affiliated personnel actors to verify that all key aspects required to properly manage samples and related data in the context of paediatric trials are taken into consideration.
- A visual algorithm based on the Naranjo scale and specifically adapted for the paediatric population to help researchers in their assessment of causality of adverse events occurring during a clinical study.
Our second session of the PedCRIN webinar series will be focused on patient engagement in clinical research, specifically on the involvement of families and young people. The speakers are Eric Vermeulen from VSOP (Dutch Patient Alliance for Rare and Genetic Diseases) and Begonya Nafria from FSJD (Sant Joan de Déu Research Foundation).
In order to develop efficient paediatric clinical trials, it is essential to involve patients and families. Within the PedCRIN project, we have analysed different models of involving patients and families in academic studies. In this webinar, we will share lessons learned through the application of these models and will explain how you can plan patient involvement in your studies.
Recording link coming soon ....
Our third webinar will be dedicated to the tools for managing neonatal clinical trials. The speakers are Prof Evelyne Jacqz-Aigrain and Dr Beate Aurich from INSERM (Institut national de la santé et de la recherche médicale).
This webinar will present an overview of neonatal tools providing practical points to consider for the planning of neonatal trials which were developed in the context of the PedCRIN project.
Recording link coming soon ....