The future of Italian phase I trials regulation: lessons from a nationwide survey
While AIFA Determination 809/2015 has strengthened safety and quality culture, it imposes significant operational burdens, especially on academic institutions. Targeted revision appears necessary to maintain high standards while improving sustainability and competitiveness of Italian phase I research.
Authors
- Stefano Stabile (ORCID: https://orcid.org/0000-0003-0040-485X)
- Alessandra Ferrari (ORCID: https://orcid.org/0000-0001-7354-9895)
- Francesca Mannozzi
- Veronica Franchina
- Marta Betti (ORCID: https://orcid.org/0000-0002-1372-6666)
- Celeste Cagnazzo (ORCID: https://orcid.org/0000-0003-4055-3139)
- Sara Testoni (ORCID: https://orcid.org/0000-0001-6141-8783)
- Irene Federici
- Linda Penolazzi (ORCID: https://orcid.org/0009-0005-7052-3696)
Institutions
- Marche Polytechnic University (IT)
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Ospedale Regina Margherita (IT)
- Policlinico San Matteo Fondazione (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo (IT)
- Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte (IT)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2025-11-12
- DOI
- https://doi.org/10.3389/fmed.2025.1709108
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00