A Delphi process to optimize quality and performance of drug evaluation in neonates

• Published in: PloS one Vol. 9; no. 9; p. e104976
• Main Authors: Legrand, Frederic, Boulkedid, Rym, Elie, Valery, Leroux, Stephanie, Valls, Elizabeth, Valls-i-Soler, Adolfo, Van den Anker, Johannes N, Jacqz-Aigrain, Evelyne
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 11.09.2014; Public Library of Science (PLoS)
• Subjects: Adult; Birth weight; Clinical trials; Clinical Trials as Topic; Collaboration; Committees; Criteria; Delphi method; Delphi Technique; Drug Evaluation; Education; Ethical standards; Ethics; Evaluation; FDA approval; Female; Hospitals; Humans; Infant, Newborn; Infrastructure; Initiatives; Intensive care; Intensive Care Units; International standardization; Male; Medical ethics; Medicine and Health Sciences; Middle Aged; Neonates; Newborn babies; Newborn infants; Pediatrics; Pharmaceutical industry; Pharmacology; Pharmacology - methods; Physicians; Public involvement; Quality management; Questionnaires; Research and Analysis Methods; Studies; Training; Vermont; France; United States > US; Spain
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0104976

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. 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. 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. 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.