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Platform trials()

For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rap...

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Autores principales: Roustit, Matthieu, Demarcq, Olivier, Laporte, Silvy, Barthélémy, Philippe, Chassany, Olivier, Cucherat, Michel, Demotes, Jacques, Diebolt, Vincent, Espérou, Hélène, Fouret, Cécile, Galaup, Ariane, Gambotti, Laetitia, Gourio, Charlotte, Guérin, Aurélie, Labruyère, Carine, Paoletti, Xavier, Porcher, Raphael, Simon, Tabassome, Varoqueaux, Nathalie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756081/
https://www.ncbi.nlm.nih.gov/pubmed/36529559
http://dx.doi.org/10.1016/j.therap.2022.12.003
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author Roustit, Matthieu
Demarcq, Olivier
Laporte, Silvy
Barthélémy, Philippe
Chassany, Olivier
Cucherat, Michel
Demotes, Jacques
Diebolt, Vincent
Espérou, Hélène
Fouret, Cécile
Galaup, Ariane
Gambotti, Laetitia
Gourio, Charlotte
Guérin, Aurélie
Labruyère, Carine
Paoletti, Xavier
Porcher, Raphael
Simon, Tabassome
Varoqueaux, Nathalie
author_facet Roustit, Matthieu
Demarcq, Olivier
Laporte, Silvy
Barthélémy, Philippe
Chassany, Olivier
Cucherat, Michel
Demotes, Jacques
Diebolt, Vincent
Espérou, Hélène
Fouret, Cécile
Galaup, Ariane
Gambotti, Laetitia
Gourio, Charlotte
Guérin, Aurélie
Labruyère, Carine
Paoletti, Xavier
Porcher, Raphael
Simon, Tabassome
Varoqueaux, Nathalie
author_sort Roustit, Matthieu
collection PubMed
description For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.
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spelling pubmed-97560812022-12-16 Platform trials() Roustit, Matthieu Demarcq, Olivier Laporte, Silvy Barthélémy, Philippe Chassany, Olivier Cucherat, Michel Demotes, Jacques Diebolt, Vincent Espérou, Hélène Fouret, Cécile Galaup, Ariane Gambotti, Laetitia Gourio, Charlotte Guérin, Aurélie Labruyère, Carine Paoletti, Xavier Porcher, Raphael Simon, Tabassome Varoqueaux, Nathalie Therapie Giens Workshops 2022 For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities. Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. 2023 2022-12-05 /pmc/articles/PMC9756081/ /pubmed/36529559 http://dx.doi.org/10.1016/j.therap.2022.12.003 Text en © 2022 Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Giens Workshops 2022
Roustit, Matthieu
Demarcq, Olivier
Laporte, Silvy
Barthélémy, Philippe
Chassany, Olivier
Cucherat, Michel
Demotes, Jacques
Diebolt, Vincent
Espérou, Hélène
Fouret, Cécile
Galaup, Ariane
Gambotti, Laetitia
Gourio, Charlotte
Guérin, Aurélie
Labruyère, Carine
Paoletti, Xavier
Porcher, Raphael
Simon, Tabassome
Varoqueaux, Nathalie
Platform trials()
title Platform trials()
title_full Platform trials()
title_fullStr Platform trials()
title_full_unstemmed Platform trials()
title_short Platform trials()
title_sort platform trials()
topic Giens Workshops 2022
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756081/
https://www.ncbi.nlm.nih.gov/pubmed/36529559
http://dx.doi.org/10.1016/j.therap.2022.12.003
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