Center for health regulatory policies

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 and to propose solutions aligning the 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

Drug regulatory processes

- Critical assessment of clinical trials supporting the marketing approval of new drugs in Europe, focusing on non-inferiority designs, abuse of placebo as comparator, use of surrogate outcome measures, etc.

- Critical analysis of clinical studies evaluating the switch between biologic drugs and their biosimilars (in collaboration with the World Health Organization).

- Preparation of applications and support to the decisional process for the inclusion of drugs in the WHO Essential Medicine Lists.

- Critical assessment of evaluation criteria and processes adopted by the regulatory authorities, innovation of new drugs, transparency of clinical trials and regulatory processes, including the publication of documents and data submitted by the pharmaceutical companies to obtain the marketing authorization.

Clinical research methodology and promotion of independent research

-  The PERsonalised MedicIne Trials (‘PERMIT’) project on methodological standards for personalised medicine research (H2020 project).

- Promotion of independent clinical research through the participation in the European Clinical Research Infrastructure Network (ECRIN) and network CRIGH (The Clinical Research Initiative for Global Health)

-  Planning and conduction of educational programs on clinical trial and evidence syntheses methodology.

Rational use of biologic drugs

- Development of novel laboratory approaches to optimize the clinical efficacy and safety of biological medicines and their biosimilars (in collaboration with the Laboratory of Pharmacodynamics and Pharmacokinetics of the Mario Negri Institute).

- Planning and conduction of educational programs on biosimilars and drug monitoring addressing physicians and other health professionals of the Tuscany Region.

Clinical research and decision-making processes

- Clinical trials on prophylactic surgery plus HIPEC with CO2 in patients affected by colorectal carcinoma and gastric carcinoma (in collaboration with the Laboratory of Clinical Trials of the Mario Negri Institute).

- Planning and conduction of evidence syntheses and HTA reports in the field of surgery and on the assessment of carrier status of cystic fibrosis.

Senior Advisor

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