Description
The Phase I Clinical Unit is part of the Advanced Clinical Research and Innovation Directorate, within the Scientific Directorate, and works in close collaboration with the Health Directorate, General Management, and all clinical units of the Institute.
The Unit plays a central role in the advancement of oncology research, contributing to the development of new drugs and ensuring clinical activities according to the principles of Good Clinical Practice and in compliance with national and international regulations.
Its mission is to provide patients with access to the most innovative cancer therapies, turning preclinical research findings into practical and safe treatments.
Self-certified by AIFA in 2018 (code FI/171), the Unit is organized according to national and international regulatory standards and has advanced technological and professional resources that enable it to conduct Phase I trials with high levels of safety, quality, and regulatory compliance.
ThePhase 1 Clinical Unit includes 8 beds dedicated to patients involved in Phase I studies, distributed between the Day Hospital and the Oncology Inpatient Unit. The clinical activity is supported by the Phase I Laboratory Unit (code FI/172), also self-certified AIFA as of 2018, which expertly handles biological samples and all analyses required for early studies.
Responsibility
The Phase I Unit coordinates the entire pathway of clinical trials, from assessing the feasibility of studies to establishing operating procedures, to staff training and ongoing monitoring of patient safety and clinical outcomes.
Main responsibilities include:
- Management of clinical pathways and any emergencies;
- Compliance with AIFA 809/2015 requirements and maintenance of the quality system;
- Management and traceability of experimental drugs;
- Filing and management of regulatory documentation;
- Organization of information flows with sponsors and CROs;
- supervision of data monitoring, entrusted to Clinical Research Coordinators dedicated to each therapeutic area.
The Unit also works in close synergy with the following divisions:
Innovative therapies
“Innovative therapies” are defined as next-generation approaches that complement or surpass traditional cancer therapies, including:
- Immunotherapy: stimulates or modulates the immune system to recognize and fight cancer cells
- Targeted therapies (targeted therapy): act on specific biological mechanisms of the tumor
- Cell therapies: cells harvested and modified in the laboratory to selectively target disease
- New antibodies, bispecific antibodies, and ADCs: enable drug delivery directly into tumor cells, increasing the precision of treatment
- Cancer vaccines: aimed at stimulating a therapeutic or preventive immune response
- Radioconjugates: combine an antibody with a radioactive isotope to focus radiation on the cancer cell, reducing the exposure of healthy tissue.
Dedicated space, advanced monitoring technologies , and specialized staff allow these new treatments to be developed rapidly, giving patients access to cutting-edge care from the earliest stages of experimentation.
Contact
The Phase I Clinical Unit is the point of contact for sponsors, CROs, ethics committees, internal investigators, and Institute facilities involved in early studies.
The Unit can be contacted for inquiries regarding submission and activation of Phase I studies, feasibility assessment, operational coordination, access to procedures and quality documentation, and scientific and industrial collaborations in the field of early oncology drug development.
- Active clinical trials: ufficio.trials@ircc.it
- Activation of new clinical trials: clinicalstudy.startup@ircc.it
