title: A Delphi process to optimize quality and performance of drug evaluation in neonates.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: AP-HP (Assistance Publique des Hôpitaux de Paris), Department of Paediatric Pharmacology and Pharmacogenetics, Inserm CIC 9202 (Centre d'Investigation Clinique pédiatrique), University Diderot Paris VII, Hôpital Robert Debré, Paris, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Legrand
authors.affiliation: AP-HP (Assistance Publique des Hôpitaux de Paris), Unité de Recherche Clinique (URC), Inserm CIE5 (Centre d'Investigation clinique Epidémiologie clinique), Hôpital Robert Debré, Paris, France.
authors.forename: Rym
authors.initials: R
authors.lastname: Boulkedid
authors.affiliation: AP-HP (Assistance Publique des Hôpitaux de Paris), Department of Paediatric Pharmacology and Pharmacogenetics, Inserm CIC 9202 (Centre d'Investigation Clinique pédiatrique), University Diderot Paris VII, Hôpital Robert Debré, Paris, France.
authors.forename: Valery
authors.initials: V
authors.lastname: Elie
authors.affiliation: AP-HP (Assistance Publique des Hôpitaux de Paris), Department of Paediatric Pharmacology and Pharmacogenetics, Inserm CIC 9202 (Centre d'Investigation Clinique pédiatrique), University Diderot Paris VII, Hôpital Robert Debré, Paris, France.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Leroux
authors.affiliation: University of Basque country, Head Neonatal Intensive care Unit, Cruces University Hospital, Barakaldo-Bilbao, Spain.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Valls
authors.affiliation: University of Basque country, Head Neonatal Intensive care Unit, Cruces University Hospital, Barakaldo-Bilbao, Spain.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Valls-i-Soler
authors.affiliation: Evan and Cindy Jones Professor of Paediatric Clinical Pharmacology Chief, Division of Clinical Pharmacology, Children's National Health System, Washington, District of Columbia, United States of America.
authors.forename: Johannes N
authors.initials: JN
authors.lastname: Van den Anker
authors.affiliation: AP-HP (Assistance Publique des Hôpitaux de Paris), Department of Paediatric Pharmacology and Pharmacogenetics, Inserm CIC 9202 (Centre d'Investigation Clinique pédiatrique), University Diderot Paris VII, Hôpital Robert Debré, Paris, France.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D003697:Delphi Technique; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010600:Pharmacology / Q000379:methods; D010820:Physicians