Widespread infrastructure of ACC Institutes to support research
A resolute commitment of the Italian system to the evolution of oncology towards “personalized medicine,” clinical trials with innovative designs and public-private collaboration are required to be competitive in the European scenery scene. Rapid progress in treatment creates new challenges that demand redefining priorities in terms of scientific organization.
With the advent of the new Italian and European legislation requiring all clinical trials to be conducted according to the GCP principles, it becomes possible to promote academic studies for registration purposes. All this makes it necessary to develop an efficient infrastructure that supports the development of academic studies and the collaboration between the public and private systems. This infrastructure must ensure the creation of high-quality data, respecting compliance with the principles of GSP.
The FORZA project stems from the realization that several Italian research institutions (IRCCS) belonging to the ACC network already have “Clinical Trial Units” that can participate in the establishment of academic infrastructure, under the supervision of ACC, generating a “roadmap” of academic research in clinical and translational fields. The infrastructure in question will allow IRCCS to play the role of promoters receiving procedural guarantees that enable the generation of grounded and expendable results for registration purposes.
On behalf of ACC, FORZA wants to develop an efficient academic infrastructure by combining the knowledge and expertise of all the IRCCS involved.
Lines of development:
For the development of Forza, three priority lines have been identified:
Tutoring of a group of academic clinical monitors, in collaboration with the Italian National Institute of Health, AIFA and the Ministry of Health - course carried out between March and May 2021
Based on the experience of the National Cancer Institute of Naples, development of an IT platform capable of managing all phases of clinical trials and experimental projects.
Operating team creation for centralized management of studies through the digital platform to coordinate ACC clinical trials.
Sandro Pignata - Paolo Pronzato
The scientific coordination of the project is shared between Dr. Sandro Pignata (IRCCS Foundation Pascale Naples) and Dr. Paolo Pronzato (IRCCS San Martino Hospital)