Support mechanisms for non-commercial clinical trials | Level | |||||||
National | EU Level (Multinational) | Global | ||||||
Dedicated webpage | ||||||||
Training courses | ||||||||
Scientific advice | ||||||||
Helpdesk, regulatory, CTIS and ethics support |
| X | X | X | ||||
Other services by National Competent Authority | NCA fee reduction or waiver As per the Ministerial Decree of 30 November 2021, no fees are requested for the submission of the Clinical Trial Application (full fee waiver). | X | X | X | ||||
Services by ethics committee | As per the Ministerial Decree of 30 November 2021, no fees are requested for the submission of the Clinical Trial Application (full fee waiver). | X | X | X | ||||
Public GCP support | ||||||||
Public research office | AIFA Independent research office: financial support to non-commercial clinical studies and clinical trials AIFA's independent research programme is aimed at all Italian researchers from public and non-profit institutions. The research programme is financed by a share of a national fund consisting of a contribution equal to 5% of the promotional expenses incurred annually by pharmaceutical companies. Studies supported by the Agency are those aimed at:
Calls for funding of independent research are usually published periodically and are constantly updated, in order to suit to the new needs arising in the health sector. The Office also provides general support to non-commercial sponsors on regulatory issues, if requested. International studies can be covered, however the funding is limited to national sites and researchers only. General Directorate of research and Innovation at the Ministry of Health: The Directorate publishes a public call on a yearly basis for grants on clinical and nonclinical studies and clinical trials performed by the Institutes for Hospital care and Research (IRCCS), with a dedicated section for young investigators. | X | ||||||
National funding and other financial support |
| X | ||||||
Funding coordination and navigation of research infrastructure | ||||||||
Support identifying research networks | ||||||||
Other support mechanisms | Additional costs of non-commercial trials can be covered by dedicated funds, which are mandatory for public health institutions according to Ministerial Decree of 30 November 2021. These funds can be constituted by specific research funds already available at the clinical site and can be further financed by revenues related to contracts with commercial sponsors for the conduct of commercial clinical trials at the concerned clinical site. | X |