Cargando…

Festina lente

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Petrini, Carlo, Ricciardi, Walter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
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
_version_ 1783739795072090112
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