Festina lente.
Contemp Clin Trials Commun
; 23: 100837, 2021 Sep.
Article
in English
| MEDLINE | ID: covidwho-1363945
ABSTRACT
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Contemp Clin Trials Commun
Year:
2021
Document Type:
Article
Affiliation country:
J.conctc.2021.100837
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