Clinical and Molecular Epidemiology and Biostatistics.

Bonassi Stefano

 Patrizia Russo, Proietti Stefania, Vitiello Laura, Francesca Milani, Cristina Rotondi, Thouant Carrie Louise

The research activity of the Clinical and Molecular Epidemiology area is characterized by an overview of the etio-pathogenesis and rehabilitative treatment of major noncommunicable diseases from a personalization perspective. This approach is in accordance with recent rehabilitation guidelines. Research objectives include. 1) Initiate understanding of precision medicine approaches related to rehabilitation medicine and 2) Characterize biomarkers associated with specific injuries, diseases, or disorders that are prognostic or guide the prescription of rehabilitation interventions. This approach, applied to different disabilities, integrates areas of modern clinical medicine with biomarkers and genetic research. In addition to genetic biomarkers, individual factors, psychological traits, and environmental variables may influence the association between a subject’s biology and response.

The ‘area also consists of a Clinical Epidemiology and Biostatistics Unit provides the fundamental contribution to the research design and statistical analysis of observational studies and the randomized clinical trials conducted with the direct participation of the area, as well as giving statistical and epidemiological consulting services to the facilities of San Raffaele in all phases of research from the evaluation of the “sample size” to the writing of the final report and the publication of the results.

Gli obiettivi

The group’s activities are structured into two areas:
Clinical Epidemiology and Biostatistics Unit-Dedicated to clinical and epidemiological study design and statistical analysis of studies, in the Scientific Directorate, provides a service for all research groups at St. Raphael in addition to proposing and managing research in the area.
Molecular Epidemiology Laboratory – is in charge of sample management and archiving for studies organized by the area or conducted in collaboration with other groups, as well as conducting its own studies on markers of genomic instability and DNA damage.

The research approach used is predominantly translational in nature so that purely molecular field assessments and clinical outcome indicators can be integrated.

Gli interessi dell’Area

Research activity was initially focused in the field of pulmonology and gradually expanded to other diseases such as cardiovascular and neuropsychiatric. The topics covered so far have been: evaluation of the role of Respiratory Rehabilitation on functional outcome parameters and Quality of Life (QoL) in patients undergoing lung resection surgery for neoplasm; evaluation of correlations between Chronic Obstructive Pulmonary Disease (COPD), respiratory function and Erectile Dysfunction (ED); evaluation of the consistency of clinical outcome indices (BODE index) in measuring the clinical effectiveness of Respiratory Rehabilitation; molecular markers (patterns of inflammation and oxidative stress) of outcome and correlation between COPD and cardiovascular disease. More recently, with the implementation of systems approaches and the launch of a respiratory pathology platform, several studies have been planned to identify clusters of variables to more comprehensively define the rehabilitation outcome, as well as to identify predictors of response and individualize treatment.
Among the most studied mechanisms is oxidative stress, and peripheral biomarkers have been measured to assess its role in the etiopathogenesis of COPD and also other diseases including psychiatric pathology and autism in particular.
Activities in this area are supported by clinical standardization and laboratory activity aimed at optimizing the management of available resources with planning to enable the development of appropriate plans for technology transfer of valuable knowledge in the commercial arena (according to standard criteria for the protection and exploitation of Intellectual Property). With this in mind, agreements are being established to activate collaborations in the areas of proteomics, advanced genomics (“Next Generation Sequencing”) and Bioinformatics. Contacts were also established with the European network of centers active in the field of Systems Medicine, collaborations that led IRCCS San Raffaele Pisana to become one of the founding members of the European Institute of Systems Biology and Systems Medicine, based in Lyon, France.
The activities of both working groups have a strong commitment to the field of geriatrics. The Sc@rabeo project, aimed at collecting and managing a multidimensional database of data collected from geriatric patients admitted to the San Raffaele Group’s RSAs (more than 1,200 beds), has been launched. This project aims to include all patients received at the group’s RSAs in the database, while also creating a national collaborative network with other geriatric research groups. In addition, activities have been initiated in the geriatric setting aimed at identifying genomic, epigenomic, and immunologic predictors of frailty, a condition strongly associated with disability and mortality whose prevention and treatment can consistently improve quality and length of life in the elderly.
Sponsored clinical research activities centered mainly on the evaluation of the feasibility, safety and efficacy of investigational drug treatments continued during 2014. Respiratory rehabilitation departments have been involved in several prestigious studies, including a single-center study devoted to the trial of heparin in patients with COPD, the results of which could provide a major breakthrough in COPD therapy.
The group’s scientific interests place aspects of potential transferability (technological and managerial) to the National Health System among its priorities. In this regard, the implementation of a Research plan began, which allowed the analysis of the potential expansion of indications related to Respiratory Rehabilitation in discharged patients who could continue at home the treatment started in the hospital thanks to ICT (Information and Communication Technology) technologies. The group’s interest in this area is also evidenced by the awarding of two projects funded by the Center for Disease Control (CCM) of the Ministry of Health for projects related to the identification, coding and clinical-organizational management of complexity in medicine.
In terms of broadening specific research interests, research in immunology, genetics-genomics, and epidemiology (molecular and clinical epidemiology) has been activated. These, together with the already established one for Molecular and Cellular Biology allow a completion of the translational potential of the Research Area with the enlargement to fields of great innovative value such as nanotechnology diagnostics, Genome Wide Association Studies (GWAS), epidemiological studies for the analysis of gene/environment interaction (Gene to Environment Interaction). Also in the area of biomarker collaborations, the group has the conduct of the epidemiological part of large international projects such as the HUMN and ComNet, dedicated to the validation of gnomic instability and DNA damage markers.

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