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. 2014 Sep 11;9(9):e104976.
doi: 10.1371/journal.pone.0104976. eCollection 2014.

A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

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Free PMC article

A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Frederic Legrand et al. PLoS One. .
Free PMC article

Abstract

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently.

Methodology and main findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description-Level of care" (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience" (12), "Scientific competencies and area of expertise" (8), "Quality Management" (16), "Training and educational capacity" (8) and "Public involvement" (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings.

Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of.

Summary points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings--"NICUs description-Level of care" (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience" (12), "Scientific competencies and area of expertise" (8), "Quality Management" (16), "Training and educational capacity" (8) and "Public involvement" (6)--47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Flowchart of the Delphi process.

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References

    1. Jacqz-Aigrain E, Kaguelidou F, van den Anker JN (2012) How to optimize the evaluation and use of antibiotics in neonates. Pediatr Clin North Am 59: 1117–1128 10.1016/j.pcl.2012.07.004 - DOI - PMC - PubMed
    1. Ellsbury DL, Ursprung R (2012) A quality improvement approach to optimizing medication use in the neonatal intensive care unit. Clin Perinatol 39: 1–10 10.1016/j.clp.2011.12.001 - DOI - PubMed
    1. CHMP & PDCO - “Guideline on the investigation of medicinal products in the term and preterm neonate” (2009) Guideline on the investigation of medicinal products in the term and preterm neonate. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003750.pdf.
    1. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, et al. (2003) Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med 349: 1157–1167 10.1056/NEJMra035092 - DOI - PubMed
    1. Tod M, Jullien V, Pons G (2008) Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet 47: 231–243 10.2165/00003088-200847040-00002 - DOI - PubMed

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Grant support

The research leading to these results has received funding from the European Union Seventh Framework Programme FP7/2007-2013 under grant agreement no. 261060 (Global Research in Paediatrics 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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