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The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Co...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372446/ https://www.ncbi.nlm.nih.gov/pubmed/34423173 http://dx.doi.org/10.1016/j.conctc.2021.100837 |
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author | Petrini, Carlo Ricciardi, Walter |
author_facet | Petrini, Carlo Ricciardi, Walter |
author_sort | Petrini, Carlo |
collection | PubMed |
description | The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19. Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally. |
format | Online Article Text |
id | pubmed-8372446 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-83724462021-08-18 Festina lente Petrini, Carlo Ricciardi, Walter Contemp Clin Trials Commun Article The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19. Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally. Elsevier 2021-08-18 /pmc/articles/PMC8372446/ /pubmed/34423173 http://dx.doi.org/10.1016/j.conctc.2021.100837 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Petrini, Carlo Ricciardi, Walter Festina lente |
title | Festina lente |
title_full | Festina lente |
title_fullStr | Festina lente |
title_full_unstemmed | Festina lente |
title_short | Festina lente |
title_sort | festina lente |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372446/ https://www.ncbi.nlm.nih.gov/pubmed/34423173 http://dx.doi.org/10.1016/j.conctc.2021.100837 |
work_keys_str_mv | AT petrinicarlo festinalente AT ricciardiwalter festinalente |