SPOKE 8
Clinical Trials
Clinical validation and implementation of innovative precision medicine approaches—predictive, preventive, diagnostic, and therapeutic—based on established or emerging molecular and clinical phenotyping and artificial intelligence–driven decision protocols.
Spoke Leader and Expertise
The University of Pisa is recognized at both national and international levels for its strong expertise in clinical trials, medical oncology, the evaluation of innovative therapies, and the conduct of complex multicenter clinical studies. Within the framework of precision medicine, the University integrates clinical, methodological, and regulatory expertise to ensure that scientific innovations are tested and validated according to rigorous standards of safety, efficacy, and sustainability.
Within HEAL Italia, Spoke 8 represents the final step of the value chain, that is, the point where results generated by the other Spokes are translated into real clinical practice.
Partners
- IRCCS IFO – Istituti Fisioterapici Ospitalieri
- Istituto di Ricerche Farmacologiche Mario Negri
- IRCCS Azienda Ospedaliero-Universitaria di Bologna S. Orsola
- Sapienza Università di Roma
- Fondazione Toscana Life Sciences
- Università degli Studi di Roma Tor Vergata
- Alma Mater Studiorum Università di Bologna
- Università degli Studi di Cagliari
- Università degli Studi di Catania
- Università degli Studi di Milano-Bicocca
- Università degli Studi di Modena e Reggio Emilia
- Università degli Studi di Palermo
- Università degli Studi di Verona
- UPMC Italy – University of Pittsburgh Medical Center
Scientific Coordinators
Prof. Chiara Cremolini
Prof. Piero Marchetti
Mission
The mission of the thematic network (Spoke 8) is to ensure that precision medicine becomes an integral part of everyday clinical practice. In this context, clinical trials represent a fundamental tool for verifying the safety, efficacy, and impact of innovations developed across the entire HEAL Italia value chain.
Spoke 8 works to transform biomarkers, predictive models, therapies, and advanced technologies into solid clinical evidence that can be transferred to the National Health Service.
Objectives
- Clinically validate the scientific results produced by the other Spokes.
- Promote the adoption of precision medicine within the National Health Service.
- Improve the quality and appropriateness of care pathways.
- Contribute to the standardization of innovative clinical protocols.
Activities
The activities of Spoke 8 include the design, coordination, and conduct of multicenter clinical studies involving hospitals, IRCCS, and universities across the national territory. The Spoke supports all phases of clinical trials, from protocol definition to study execution, as well as data analysis and interpretation of results.
A central area concerns the validation of integrated diagnostic-therapeutic care pathways, that is, organizational models that combine diagnosis, treatment, and patient follow-up. These pathways are developed in collaboration with the other Spokes and tested in real clinical settings.
The Spoke also works on the generation of real-world evidence, that is, evidence derived from everyday clinical practice, which complements the results of controlled studies with data from the real-world use of therapies and technologies.
The activities also include methodological and regulatory support for clinical trials, training of the healthcare personnel involved, and dissemination of results within the clinical and scientific community.
Areas of work
Optimization of therapeutic resources: from predictive biomarkers to targeted treatments
- Detection of clinical heterogeneity and dynamic evolution of diseases
- Identification of predictors of benefit for available treatments
- Prediction of treatment-related toxicity
- Prediction of all-cause mortality in patients with diabetes
Beyond the “crystal ball”: improving prognosis in tumors and cardiometabolic diseases
- Circulating markers of minimal residual disease: liquid biopsies and ctDNA analysis for recurrence prediction
- Clinical, genomic, and epigenetic outcome markers in neoplasms and cardiometabolic diseases
- Characterization of behavior, aggressiveness, and prognosis of colorectal cancer (CRC) through radiogenomic signatures
Reverse Translation: from patient to laboratory and back
- Identification of opportunities for clinical drug repurposing
- Identification of mechanisms of acquired resistance to treatments for the selection of pharmacological candidates for clinical trials
- “As a matter of fat”: the role of adipose tissue and lipid metabolism in diseases
- Molecular, mutational, radiomic, and histomorphological profiling of hepatobiliopancreatic (HBP) tumors: the right treatment for the right patient at the right time
From theory to reality: precision medicine ready for clinical implementation
- Building networks for the integration of precision medicine into everyday clinical practice
- Evaluation of the cost-effectiveness of available technologies for the sustainability of the healthcare system
- From extended theoretical models to proof of concept in the clinical setting
From the laboratory to the patient’s bedside: evaluation and implementation of precision medicine technologies in clinical care
- Building networks for the integration of precision medicine into everyday clinical practice
- Evaluation of the cost-effectiveness of available technologies for the sustainability of the healthcare system
- From extended theoretical models to proof of concept in the clinical setting
- Identification of core components and key aspects of the HTA evaluation process for innovative technologies
- Development of a standardized approach for clinical validity and utility of precision technologies: an HTA framework to promote clinical implementation
Projects Funded through Cascade Calls
MOCCARDIS
Multi-omics characterization of human samples derived from cardiometabolic disorders affected patients
The project aims to systematically acquire and integrate genomics, transcriptomics, proteomics, and metabolomics data to build detailed multi-omics profiles from clinical samples, promoting a deeper understanding of the molecular complexities underlying cardiometabolic disorders. Through this multidimensional analysis, the initiative seeks to enhance diagnostic tools and refine personalized medicine strategies by deciphering the underlying mechanisms that drive disease development and progression, enabling more effective and targeted treatments. The integration of these different biological layers overcomes the limitations of individual omics analyses, transforming the richness of molecular data into actionable clinical knowledge that places the patient at the center of an evidence-based and precision-driven care pathway.
CLINHUB
Hub di coordinamento e conduzione degli studi clinici
The technical-scientific support activity integrates the drafting and critical review of essential regulatory documentation (from the study protocol and informed consent to the Investigator’s Brochure and the Clinical Study Report) with the strategic coordination of the authorization process, managing each phase from initial submission to final approval by adapting the dossier to national and local requirements. This operational workflow is strengthened by continuous monitoring of field activities, including initiation, monitoring, and close-out visits, supported by data management focused on maximum integrity through the development of eCRFs, data cleaning procedures, and the rigorous execution of statistical analysis plans for the production of high-quality final reports.
SUCCESS
Clinical utility and economic sustainability of outsourced services of Comprehensive Genomic Profiling (CGP) for solid tumors in practice oncology clinic
The project aims to demonstrate the effectiveness and efficiency of an innovative approach based on extended genomic profiling as a key enabling technology for precision medicine. The results will provide evidence to establish a new routine of personalized clinical practice in oncology.
