The Centre is responsible for the critical evaluation of clinical research methodology, pharmaceutical legislation and policies with a view to raising awareness among the scientific community and the public about potential constraints and distortions in drug decision-making, to propose solutions aligning rules with public health needs. The activity is also focused on the promotion of independent clinical research through participation in the development and implementation of a European infrastructure to support the planning and conduct of clinical trials.
Main Projects
regulatory pOLICIES
- Critical analysis of legislation and regulations in health, evaluation mechanisms of regulatory agencies, transparency of processes and evidence to support the approval of medicines and other health interventions.
- Production of systematic reviews on pharmacological treatments for the treatment of obesity (in collaboration with the World Health Organization).
- Expert centre of the European infrastructure EATRIS (European infrastructure for translational medicine, https://eatris.eu/eatris-expert-centres/) for regulatory support services and early health technology assessment
Clinical research and decision-making processes
- Collaboration with the Clinical Research Laboratory of the Mario Negri Institute for the implementation of randomized studies on the use of intraperitoneal chemotherapy in the oncology field.
- Preparation of systematic reviews (bariatric surgery for the treatment of obesity in collaboration with the World Health Organization) and health technology assessment reports in the surgical field.
- Organization of training courses on the methodology of clinical research applied to the surgical field.
research promotion
- OSIRIS project (Open Science to Increase Reproducibility in Science, https://osiris4r.eu/) for the development and evaluation of interventions aimed at improving the reproducibility of research.
- Collaboration with the European research infrastructures ECRIN (European Clinical Research Infrastructure Network, www.ecrin.org/) and with the CRIGH network (The Clinical Research Initiative for Global Health, https://crigh.org/).
- Collaboration with the Pharmacogenomics Unit of the Laboratory of Human Pathology in Model Organisms for the EATRIS CONNECT project (https://eatris.eu/projects/eatris-connect/) for digital transformation in translational medicine.
- Collaboration with the Laboratory of Clinical Epidemiology for the eCREAM project (enabling Clinical Research in Emergency and Acute care Medicine, https://ecreamproject.eu).
- Promotion of gender-specific medicine and research.
