One of the main objectives of PedCRIN project is 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. For this purpose, PedCRIN Work Package 3 (WP3), coordinated by CVBF and INSERM, have developed a complete collection of tools addressed to professionals working on these two main areas of clinical research. Some of these tools have been created from scratch and others have been adapted or upgraded from pre-existing ones taking into consideration the particularities of paediatric population.
The first step was to study the current status of public European paediatric clinical research with the aid of a survey on infrastructure and service needs and a gap analysis based on the data extracted from the survey. The survey targeted paediatric and neonatal users as well as patient communities to identify the needs of paediatricians in terms of infrastructures and tools for clinical trials. The gap analysis envisioned to detect missing tools and services to support paediatric and neonatal trials. Additional Tasks executed by WP3 in relation to these tools are:
- Upgrade, maintenance and sustainability of tools for paediatric trials (ethical and regulatory database, pharmacovigilance, etc.).
- Upgrade, maintenance and sustainability of tools for neonatal trials: setup and management.
- Development of a procedure to enable access to individual patient clinical trial data.
- Proposal of a Criteria for certification of neonatal and paediatric Clinical Trial Units to be used in the development of European standards for CTUs providing support services for the setup, management and reporting of clinical trials in children.
Finally, the project also aims at disseminating these tools so they can actually reach the experts working on paediatric multinational clinical trials in the European scenario and beyond. For that purpose, PedCRIN has created a dissemination strategy consisting of a series of communication activities aimed at spreading the word about the tools. The complete set of tools will soon be available on the PedCRIN website, so stay tuned for more updates!