Clinical Trial Support (WP4)
Clinical trial support and coordination will be the topic addressed in WP4.
Clinical trial engagement of ERNs is developing but needs further support. A main obstacle is the widespread geographic distribution of HCPs in different EU Member States with different national legislations and regulations. Moreover, knowledge of currently available innovative opportunities, procedures, and methodological solutions for trial implementation in RDs is often lacking as clearly shown by recent EJP RD and ERN Research Working Group (ERN RWG) questionnaires.
To fill this gap and avoid unnecessary duplication of tools and infrastructures, it is mandatory to collaborate with projects fostering these activities such as EJP RD (in particular Pillar 4), the European research infrastructures (BBMRI and ECRIN), patient organizations, regulators (EMA and NCAs), as well as international initiatives such as the IRDiRC network of public and private research funders and clinical research networks like RD-CRN in the US. Connection with other RD research consortia that are currently conducting/planning clinical trials (e.g. RECOMB) is foreseen as well as initiatives that are currently on-going in the paediatric field via the Conect4Children network (c4c).