Line 3 – Translational clinical research and innovative oncological therapies

Description

A characterizing and priority element of the IOV research is the conduct of innovative clinical studies on precision and translational medicine. Retrospective, observational, translational and interventional studies aimed both at optimizing the treatments already available and at the development of innovative therapies based on molecular characterization and precision medicine are also crucial for producing knowledge on the optimal treatment of patients. Another essential element is the search for predictive and prognostic factors and the use of patient reported outcomes (PROs) that evaluate the impact of new therapies on the quality of life of patients.

Background

The IOV was characterized by a continuous commitment to the direct promotion and adherence to clinical protocols for pharmacological and non-pharmacological research. The results obtained to date have made it possible to develop and promote cutting-edge skills in the conception, coordination and management of clinical and translational research initiatives. The collaboration with many Italian oncologies guarantees a competitive enrollment in international trials with innovative drugs. In the oncology field, the rapid transfer of innovative therapies to the patient’s bed guarantees many patients to benefit from new treatment opportunities in real time. The results obtained must be measured and monitored with retrospective protocols which are a valuable source of data for exploratory hypotheses to be verified longitudinally. Clinical research is the point of arrival and departure of translational projects, and is intimately related to the other lines of research of the IOV.

Rationale

The constant implementation of new clinical research has a strategic value with immediate repercussions on the patient (from the moment they enter the study), on the experience of individual researchers and research groups (from the moment of conception), on the scientific community (on presentation and publication of results). Clinical research is inherent in the mission of an IRCCS. The strategic objective is to implement translational research, and to identify predictive indicators of response to optimize the type and duration of innovative therapies (eg. Immunotherapy), in order to guarantee effective and socially sustainable treatments. These aspects cannot be separated from a 360 ° vision of the patient, in which prevention, rehabilitation, the nursing, psychological role, support, nutritional, pain and quality of life therapies find the right integration in research programs designed with methodological rigor as is the case for clinical trials.

Global Goals

• Development of non-profit studies, in particular for orphan diseases (eg glioblastoma).
• Analysis, through liquid biopsy and / or extensive molecular structure on the tumor tissue, of the characteristics of the tumor, for the search for new prognostic / predictive factors.
• Study of the tumor microenvironment and the interaction between host and tumor.
• Implementation and participation in real life studies, and the impact of multidisciplinary patient care, evaluating the medium and long-term outcomes (including patient satisfaction).
• Participation in innovative international clinical trials, particularly in the early phase.

Expected and measurable results over the three-year period

• Increase of at least 20% in the number of clinical trials active in the multicentre setting with the function of coordinator.
• Development of at least 3 multicentre independent research study proposals with coordinator function, implementation and coordination of at least 3 international initiatives.
• Promotion as coordinator of at least 5 translational studies and non-pharmacological studies, also oriented to the detection of predictive indicators of response and use of PROs as a quality of life parameter.