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

Abstract

Multicenter neonatal clinical trials aim to provide evidence-based drug evaluation, but recruiting neonates requires collaboration, standard procedures, and trained neonatologists. A questionnaire based on a previous Delphi study was sent to European neonatal intensive care units (NICUs) to collect their research experience and identify areas for improvement. Of 247 NICUs,79 (32%) responded: 69 were level III units and 10 were level II units. In level III centers, 62% had medical staff dedicated to research and 65% conducted regular in-house audits. Similarities were observed in the median number of trials per year (level II: 2; level III: 5), Good Clinical Practice training (level II: 78%; level III: 66%), and standard operating procedures (level II: 63%; level III: 71%). Most NICUs had access to scientific advice for trial design, conduct, data management, and regulatory aspects. Involvement of patient advocacy groups was more common in level II units (level II: 75%; level III: 59%). A "quality" score of 34 "quality" research items was calculated for all centers (mean: 23.2 ± 6.2; range: 6-34). 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.