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Laboratory of Drug Regulatory Policies

Research activities
Critical assessment of clinical research methodology, pharmaceutical policies and legislations in order to increase the awareness on the biases and limitations of the current decision-making processes and suggest possible solutions to better meet patient and public health needs.
Promotion of independent academic clinical research through the participation in development and implementation of the European Clinical Research Infrastructure Network (ECRIN).

Main research projects:
1.    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.
2.    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.
3.    Revision of the WHO essential medicine list 2015
http://www.who.int/topics/essential_medicines/en/
Collaboration with the World Health Organization to prepare the 20th edition of the essential drug list.
4.    Critical evaluation of clinical research and health technologies
http://www.piperska.org/home
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.
5.    Promotion of independent clinical research    
www.ecrin.org
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.

 

Annual Report 2016