The laboratory of Methodology for Clinical Research promotes and coordinates clinical trials, especially in oncology, in collaboration with national and international research groups, by combining the mission and the identity of a nonprofit research institution with high quality standards.
The laboratory is composed of doctors, computer scientists, research coordinators, statisticians, pharmacovigilance and quality assurance managers and certified monitors. It hosts a group, MaNGO, focused on gynecological tumors.
The laboratory provides also methodological and statistical advices. In particular, he is involved in the development of new statistical projects about biomarker associated drug studies, for preclinical phases as well as for early clinical phases. The aim of these projects are to evaluate the prognostic and predictive role of biomarkers and to establish their validation as surrogate endpoints.
Finally, the laboratory is involved in the production and in the implementation of systematic reviews and of oncology guidelines in methodological studies.
Methodology research in preclinical area
Many studies are being carried out to evaluate the relationship between the methodological quality of studies performed on animal models and the demonstration of the clinical activity of drugs. Furthermore, a research is carried out also for the development of statistical tests to be applied in the study of antitumor efficacy in mouse models.
Clinical studies with immunotherapy
Some clinical studies evaluate the effectiveness of drugs able to promote the activity of lymphocytes against tumor cells, in particular by removing those brakes that limit the activity of lymphocytes. The most important projects are in the field of lung, pleura, head and neck, endometrial and melanoma tumors.
Clinical studies about drug repositioning in oncology
Some drugs used for non oncological diseases could reveal antitumor activity or ability to increase the effectiveness of chemotherapy drugs. Since these drugs are generally very cheap, the potential of this kind of study could be examined only in nonprofit pharmacological research institutes, such as our institute. The main ongoing clinical studies investigating the effectiveness of drug repositioning concern breast and ovarian cancer.
Clinical studies about therapy of rare tumors and of rare subpopulations of frequent tumors
Clinical studies on rare tumors have to face with problems of difficult recruitment of patients and with the lack of invested economic resources. This kind of research requires necessarily the contribution of different clinical centers coordinated by nonprofit institutions. In our laboratory studies about new therapies for the treatment of thymomas, ovarian cancer, mesotheliomas and sarcomas are being carried out.
Clinical studies on local chemotherapy
Two clinical trials are ongoing to evaluate the efficacy of Hyperthermic IntraPeritoneal Chemotherapy (HIPEC), with the aim to control relapses in patients with gastrointestinal tract tumor, such as colon carcinoma and stomach carcinoma.
About palliative cares, projects are aimed at generating models that describe the clinical, psychological, welfare and organizational features of patients sent to the specialist palliative cares network. Prognostic models are produced based on clinical factors defined at the time of taking charge. Training courses for palliative cares staff and for general medicine doctors are also evaluated. An analysis of clinical end-of-life, diagnostic and therapeutic pathways is performed for patients with severe diseases.
Pain therapy research
Projects on pain therapy concern the evaluation of the impact of cannabinoids for the treatments of symptomatology in patients with fibromyalgia. Furthermore, this projects also aims to validate the Italian language of tests written to assess the risk of "use disorders", for patients suffering of non-cancer chronic pain, treated with opioids continuously.
Sistematic revision and guidelines activities
A continuous updating of the AIOM Guidelines (Italian Association of Medical Oncology) and production of Guidelines for AISOD (Italian Association of Dental Sedationists) and for SIAPEC (Italian Association of Pathological Anatomy) is ongoing. Furthermore, methodological support (Evidence Review Team) is provided for the production of Autism Guidelines.
International Consensus on Cardiopulmonary Resuscitation.