Our president, Karel Allegaert, participated in the paediatric committee (PDCO) scientific meeting related to the Belgian presidency that was held last week in Leuven.
Related to the ongoing revision of the EMA guideline on neonatal clinical studies, Karel discussed the progress on the neonatal adverse event severity scale (NAESS) as one of the tools to improve neonatal clinical trials.
Neonates are still commonly treated with medicines that have not been specifically labeled for this population. The International Neonatal Consortium (INC) aiming to co-create tools to improve clinical trial efficiency and success, including tools to assess efficacy and safety of medicines in neonates, has reported on the NAESS to standardize severity reporting in neonates. After the development and validation of the NAESS tool in both retro- and prospective trial design to assess its applicability and impact on the inter-observer variability, the NAESS tool has been used by regulators, sponsors and academic researchers.
Future perspectives include the accessibility to the tool and teaching abilities, further development of the NAESS tool by adding specific adverse events (AEs) not yet covered, and on the idea to provide additional standardization of AE case record forms to further improve inter-rater variability.
The NAESS tool is an important tool for neonatal clinical trials and paediatric drug development and at EPTRI we will continue to push for new paediatric research and drug developments.