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Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures
BACKGROUND: Critical care is a complex field of medicine, especially because of its diversity and unpredictability. Mortality rates of the diseases are usually high and patients are critically ill, admitted in emergency, and often have several overlapping diseases. This makes research in critical ca...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5097421/ https://www.ncbi.nlm.nih.gov/pubmed/27826449 http://dx.doi.org/10.1186/s40560-016-0191-y |
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author | François, Bruno Clavel, Marc Vignon, Philippe Laterre, Pierre-François |
author_facet | François, Bruno Clavel, Marc Vignon, Philippe Laterre, Pierre-François |
author_sort | François, Bruno |
collection | PubMed |
description | BACKGROUND: Critical care is a complex field of medicine, especially because of its diversity and unpredictability. Mortality rates of the diseases are usually high and patients are critically ill, admitted in emergency, and often have several overlapping diseases. This makes research in critical care also complex because of patients’ conditions and because of the numerous ethical and regulatory requirements and increasing global competition. Many clinical trials in critical care have thus failed and almost no drug has yet been developed to treat intensive care unit (ICU) patients. Learning from the failures, clinical trials must now be optimized. MAIN BODY: Several aspects can be improved, beginning with the design of studies that should take into account patients’ diversity in the ICU. At the site level, selection should reflect more accurately the potential of recruitment. Management of all players that can be involved in the research at a site level should be a priority. Moreover, training should be offered to all staff members, including the youngest. National and international networks are also part of the future as they create a collective synergy potentially improving the efficacy of sites. Finally, computerization is another area that must be further developed with the appropriate tools. CONCLUSION: Clinical research in the ICU is thus a discipline in its own right that still requires tailored approaches. Changes have to be initiated by the investigators themselves as they know all the specificities of the field. |
format | Online Article Text |
id | pubmed-5097421 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-50974212016-11-08 Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures François, Bruno Clavel, Marc Vignon, Philippe Laterre, Pierre-François J Intensive Care Review BACKGROUND: Critical care is a complex field of medicine, especially because of its diversity and unpredictability. Mortality rates of the diseases are usually high and patients are critically ill, admitted in emergency, and often have several overlapping diseases. This makes research in critical care also complex because of patients’ conditions and because of the numerous ethical and regulatory requirements and increasing global competition. Many clinical trials in critical care have thus failed and almost no drug has yet been developed to treat intensive care unit (ICU) patients. Learning from the failures, clinical trials must now be optimized. MAIN BODY: Several aspects can be improved, beginning with the design of studies that should take into account patients’ diversity in the ICU. At the site level, selection should reflect more accurately the potential of recruitment. Management of all players that can be involved in the research at a site level should be a priority. Moreover, training should be offered to all staff members, including the youngest. National and international networks are also part of the future as they create a collective synergy potentially improving the efficacy of sites. Finally, computerization is another area that must be further developed with the appropriate tools. CONCLUSION: Clinical research in the ICU is thus a discipline in its own right that still requires tailored approaches. Changes have to be initiated by the investigators themselves as they know all the specificities of the field. BioMed Central 2016-11-04 /pmc/articles/PMC5097421/ /pubmed/27826449 http://dx.doi.org/10.1186/s40560-016-0191-y Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Review François, Bruno Clavel, Marc Vignon, Philippe Laterre, Pierre-François Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title | Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title_full | Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title_fullStr | Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title_full_unstemmed | Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title_short | Perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
title_sort | perspective on optimizing clinical trials in critical care: how to puzzle out recurrent failures |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5097421/ https://www.ncbi.nlm.nih.gov/pubmed/27826449 http://dx.doi.org/10.1186/s40560-016-0191-y |
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