Impact of Regulation (EU) No. 536/2014 on clinical trial approval processes in two Italian oncology centers
Bencardino Daniela·Gori Stefania·Ponti Giulia·Altavilla Chiara·Rossi Laura·Verzè Matteo·Salutari Vanda·Mora Vincenzina·Malo Elvia·Inno Alessandro·Fagotti Anna·Gobbi Federico Giovanni·Marchetti Fabiana·Mazzi Cristina·Garibaldi Francesca·Ferrari Marianna·Ferrera Giulia
The new European Regulation No. 536/2014 simplified and harmonized the procedures for the submission, assessment and monitoring of clinical drug trials across Europe, with the aim of improving efficiency and accelerating patient access to innovative therapies. This study aims to compare clinical trial submission and approval timelines at two Italian oncology centres, before and after the implementation of the European Regulation, to evaluate its impact. We retrospectively analysed interval times