Research

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 general public about potential constraints and distortions in drug decision-making and to propose solutions for adapt the rules to 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 multinational academics (ECRIN) is used.

Main Projects

Critical evaluation of clinical research methodology

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 evaluation of regulatory processes

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 industry to obtain the marketing authorization.

Revision of the WHO essential medicine list 2017

Collaboration with the World Health Organization to prepare the 20th edition of the essential drug list.

Critical evaluation of clinical research and health technologies

Promotion of the rational use of medicines and public health resources. Early evaluation of the clinical and economical impact of emerging technologies (horizon scanning). Critical appraisal of clinical research aimed at developing new drugs or indications.

Promotion of independent clinical research

Promotion of independent clinical research through the participation in the European Clinical Research Infrastructure Network (ECRIN), including the coordination of the Scientific Secretariat of the ECRIN.

Staff
Chiara
Gerardi
Ricercatore
chiara.gerardi@marionegri.it
Eleonora
Allocati
Ricercatore
eleonora.allocati@marionegri.it
Vittorio
Bertele'
Ricercatore
vittorio.bertele@marionegri.it
Head
Rita
Banzi
Responsabile
rita.banzi@marionegri.it

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