Capacities and Competences for Drug Evaluation in European Neonatal Intensive Care Units: A Survey and Key Issues for Improvement

Abstract

Research experience and processes vary across Europe. Harmonizing research practices and setting standards will allow building a European neonatal network for effective, safe, and quality neonatal drug development.

Analysis of Paediatric Clinical Trial Characteristics and Activity Over 23 Years—Impact of the European Paediatric Regulation on a Single French Clinical Research Center

“…Significant initiatives have been undertaken at the European level to advance pediatric drug development including EPTRI (European Pediatric Translational Research Infrastructure) ( 21 ) and PEDCRIN (Pediatric Clinical Research Infrastructure Network) ( 22 ) and substantial financial support has been established to set up pediatric clinical research networks dedicated to trial management and to promote collaboration at the European and international level ( 23 – 25 ). However, difficulties still need to be overcome to harmonize methodological ( 26 ), regulatory ( 27 ), economic ( 28 ) and ethical ( 29 ) approaches to pediatric trials and validate tools for pediatric trial conduct ( 22 , 30 – 32 ). In addition, in our opinion, two difficulties require particular attention:…”

“…For example, at our CIC, although research is one important mission attributed to physicians, time dedicated to research, i.e., “without medical duties,” is not officially organized. In a European Delphi survey aiming to collect research experience from neonatologists and identify areas for improvement, dedicated doctors were only available at 50–60% of centers, with limited possibility to reduce clinical work, while a correlation can be seen between the amount of time a physician dedicates to clinical research and the number of subjects recruited for research studies ( 30 ). A second challenge is related to “recognition of pediatric research nurses”.…”

“…Although Robert Debré University hospital is one of the largest pediatric hospitals in France with the presence of most medical, surgical and psychiatric sub-specialties, we cannot exclude a bias of selection by the pharmaceutical industry and/or preferential recruitment by the investigators. For example, our collaborations with neonatologists and the involvement of our team in neonatal pharmacology for many years including the management or participation in important EU projects allowed for a significant but probably “center-specific” increase in drug evaluation in neonates, through local and multicenter trials ( 30 , 31 , 39 – 44 ).…”