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A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates
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 st...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Public Library of Science
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161344/ https://www.ncbi.nlm.nih.gov/pubmed/25210742 http://dx.doi.org/10.1371/journal.pone.0104976 |
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author | Legrand, Frederic Boulkedid, Rym Elie, Valery Leroux, Stephanie Valls, Elizabeth Valls-i-Soler, Adolfo Van den Anker, Johannes N. Jacqz-Aigrain, Evelyne |
author_facet | Legrand, Frederic Boulkedid, Rym Elie, Valery Leroux, Stephanie Valls, Elizabeth Valls-i-Soler, Adolfo Van den Anker, Johannes N. Jacqz-Aigrain, Evelyne |
author_sort | Legrand, Frederic |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4161344 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-41613442014-09-17 A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates Legrand, Frederic Boulkedid, Rym Elie, Valery Leroux, Stephanie Valls, Elizabeth Valls-i-Soler, Adolfo Van den Anker, Johannes N. Jacqz-Aigrain, Evelyne PLoS One Research Article 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. Public Library of Science 2014-09-11 /pmc/articles/PMC4161344/ /pubmed/25210742 http://dx.doi.org/10.1371/journal.pone.0104976 Text en © 2014 Legrand et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Legrand, Frederic Boulkedid, Rym Elie, Valery Leroux, Stephanie Valls, Elizabeth Valls-i-Soler, Adolfo Van den Anker, Johannes N. Jacqz-Aigrain, Evelyne A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title | A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title_full | A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title_fullStr | A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title_full_unstemmed | A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title_short | A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates |
title_sort | delphi process to optimize quality and performance of drug evaluation in neonates |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161344/ https://www.ncbi.nlm.nih.gov/pubmed/25210742 http://dx.doi.org/10.1371/journal.pone.0104976 |
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