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Am J Perinatol 2018; 35(06): 589-598
DOI: 10.1055/s-0038-1637766
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Valery Elie
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
,
Virginia Neyro
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
,
Phuong Ha
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
,
Beate Aurich
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
,
Stephanie Leroux
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
,
Evelyne Jacqz-Aigrain
1   Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Hospital Robert Debré, Assistance Publique–Hopitaux de Paris, Paris, France
2   Clinical Investigation Center INSERM CIC1426, Robert Debré Hospital, Paris, France
3   Department of Pharmacology, University Paris Diderot, Sorbonne Paris Cité, Paris, France
› Author Affiliations Funding The research leading to these results has received funding from the European Union Seventh Framework Program FP7 (2007–2013) under grant agreement no. 261060 (Global Research in Pediatrics Network, GRiP). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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Publication History

Publication Date:
25 April 2018 (online)

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Abstract

Background Multicenter neonatal clinical trials aim to provide evidence-based drug evaluation, but recruiting neonates requires collaboration, standard procedures, and trained neonatologists.

Methods 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.

Results 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).

Conclusion 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.

Keywords

neonate - intensive care unit - clinical research - good clinical practices - training - procedures

Authors' Contributions

V. E., V. N., S. L., and E. J. A. conceived and designed the experiments. V. E., V. N., and S. L. performed the experiments. V. E., V. N., P. H., and E. J. A. analyzed the data. V. E., V. N., P. H., B. A., S. L., and E. J. A. contributed reagents/materials/analysis tools. V. E., V. N., B. A., S. L., and E. J. A. wrote the article.


Note

The datasets generated and/or analyzed during this study are available from the corresponding author on reasonable request.