Dr. Donato Bonifazi
As part of our series of interviews with the PedCRIN Consortium members, we had the pleasure to speak with Donato Bonifazi to ask him about the role of Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in the PedCRIN project.
CVBF co-leads PedCRIN WP3 (Tools for paediatric trials) along with INSERM. The main task of this work package is to develop or adapt existing tools to be used for the management and set-up of the multinational neonatal and paediatric clinical trials, to disseminate tools to PedCRIN partners and to train and support partners on the use of the tools. In the PedCRIN project, CVBF is responsible for (i) conducting a survey targeting paediatric and neonatal users, as well as patient communities to identify the needs of paediatricians in terms of infrastructures and tools for clinical trials, (ii) performing gap analysis to detect missing tools and services to support paediatric and neonatal trials, (iii) upgrading, maintaining and ensuring the sustainability of tools for neonatal and paediatric trials (ethical and regulatory database, pharmacovigilance, etc.), (iv) disseminating tools to the paediatric community and (v) developing a procedure to enable access to individual patient clinical trial data