In the article 17 of the Legislative decree n.18 published on 17/03/2020, the Italian government provides indications on the management of clinical trials and compassionate uses for patient affected by COVID-19.
Here below a summary of the indications provided:
Limited to the COVID-19 emergency period:
- AIFA can access all the clinical trials and compassionate use data. These data concern only clinical trials and compassionate uses of medicines for patients affected by COVID-19. The clinical trials protocols are preliminarily assessed by the AIFA’s Technical Scientific Commission (CTS), which also communicates the outcomes to the Technical Scientific Committee of the Crisis Unit of the Civil Protection Department.
- The Ethics Committee of the Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani of Rome (appointed as National Ethics committee for the evaluation of clinical trials and medical devices for the treatment of patients affected by COVID-19) releases the national opinion considering also the AIFA’s CTS assessment. The Ethics Committee evaluates:
- phase II, III and IV clinical trials protocol concerning products for the treatment of patients affected by COVID-19 and relevant amendments.
- requests from doctors for compassionate uses for the treatment of patients affected by COVID-19.
After the evaluation, the national opinion is communicated to the AIFA’s CTS who publishes the final outcome on its institutional website.
AIFA within 10 days from the entry into force of this Decree will publish a Circular indicating the simplified procedures for the data acquisition as well as the methods for joining the studies.
For more details you can find the full notice at the following link: https://www.gazzettaufficiale.it/eli/gu/2020/03/17/70/sg/pdf
RPN constantly monitors AIFA website in order to stay up to date on clinical trials procedures and is available to provide full support for any query and for the submission of Clinical Trial Applications and the relevant amendments.