The Laboratory of Health Regulatory Policy critically evaluates clinical research methodology, legislation, and pharmaceutical policies to raise awareness among the scientific community and the public about potential influences and distortions affecting decision-making processes on medicines and other health technologies. It promotes and assesses solutions through national and international projects and collaboration, as well as education, training and dissemination activities.
Aims
- monitor healthcare legislation and regulations, regulatory agencies' evaluation mechanisms, and the transparency of processes and evidence supporting the approval of medicinal products and other healthcare interventions;
- promote research projects in the field of surgery, including clinical trials, systematic reviews, guidelines, and health technology assessment reports;
- promote independent clinical research and research quality through projects and collaborations with European research infrastructures.
Regulatory policies
The main projects include the analysis of the new European pharmaceutical legislation, the Joint Clinical Assessment required by the new European Health Technology Assessment (HTA) Regulation, the introduction of biosimilars of biological oncology drugs, and gender differences underlying drug withdrawals and suspensions in Europe. The Laboratory is an Expert center for the European infrastructure EATRIS (European infrastructure for translational medicine, https://eatris.eu/eatris-expert-centres/) for regulatory support services and early Health Technology Assessment. The Laboratory is involved in the preparation of a systematic review of pharmacological treatments for obesity in children and adolescents (in collaboration with the World Health Organization) and a systematic review of treatments for insomnia in the elderly (as part of the COSIsiFA project, a network of AIFA-Regions-Health Institutions for independent information on drugs).
Clinical research, education and decision-making in surgery
The Laboratory is actively involved in several projects on surgery, including randomized trials on the use of intraperitoneal chemotherapy in oncology (in collaboration with the Clinical Research Laboratory), systematic reviews of the treatment of uncomplicated acute appendicitis in children and head and neck cancers. The Laboratory coordinates the organization of training courses on clinical research methodology applied to surgery.
Research promotion
The Laboratory is partner of the European project OSIRIS (Open Science to Increase Reproducibility in Science, https://osiris4r.eu/) for the development and evaluation of interventions aimed at improving the reproducibility of research. It is also involved in the EATRIS CONNECT project (https://eatris.eu/projects/eatris-connect/) about digital transformation in translational medicine, in collaboration with the Unit of Computational Pharmacology and Toxicology of the Laboratory of Human Pathology in Model Organisms, and eCREAM project (enabling Clinical Research in Emergency and Acute care Medicine, https://ecreamproject.eu), in collaboration with the Clinical Epidemiology Laboratory. The Laboratory has recently set up the CARES Surgery Network (Collaborative Alliance for Research and Education in Surgery) to facilitate surgical research in Italy. The Laboratory also promotes and disseminates gender-specific medicine, pharmacology and research.
International Consensus on Cardiopulmonary Resuscitation.
