The workshop, co-organised by the European network of paediatric research at the EMA (Enpr-EMA) and conect4children (c4c), was held virtually on October 3, 2022. Participants included members of Enpr-EMA and of c4c, members of the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) as well as members of EMA’s Paediatric Medicines Office, along with invitees representing the pharmaceutical industry and clinical research organisations (CRO), patients and academia.
Participants discussed site suitability for participation in paediatric clinical trials and the need to identify a standardised set of quality criteria to enhance the development of high-quality trial sites and to support site selection in the context of paediatric clinical trials.
There was general agreement on the need to define quality and some kind of standardised criteria, in order to accelerate trial set-up, support site selection, ensure high-quality data and to enhance the development of sites in a collaborative process with open discussions and involving all stakeholders including sites, patients, industry and CROs, and possibly regulators.
A flexible, harmonised and global understanding that could be accepted by all the parties should be obtained to avoid potential burden to the sites.
With the aim to set up a list of criteria, three action points were identified:
1) Definition of quality: Identify different understandings of quality, scope and sources
2) Identification of standards
3) Application of standards
More information about the workshop is available here.