Sperimentazione clinica di fase I
Clinical Trials (CT) represent a fundamental moment for the promotion of health in the country because, in addition to offering the opportunity to propose and test the latest innovations in the scientific field, it increases its competitiveness in an increasingly complex global landscape.
Over the years there has been an exponential growth in authorized trials in Italy thanks to the technological innovation of new discoveries in the biomedical field and new drug development strategies. In this context, Phase I studies are characterized by a positive growth trend.
The Phase I Clinical Trial (phase 1 CT) has a great scientific value in the entire process of development and production of a drug, since it represents the passage of experimentation from the animal (preclinical) to man, with the aim of verifying for the first time if the conditions of applicability and veracity of the data obtained are met in order to be able to continue with the subsequent phases of the research. The cornerstone of the phase 1 CT is therefore to provide a first assurance of safety and tolerability of the first dose to be administered, which is why this phase represents a critical step in the development process of a new drug.
Biological and biotechnological drugs, at present, represent the most developed class of drugs with application mainly in the oncological field, but also in the treatment of pathologies of the nervous, immune, hemolymphatic and many other systems.
Since 1973, Italian legislation has entrusted the Istituto Superiore di Sanità (ISS) with the technical-scientific evaluation of the requests for authorization submitted by the proposers on the national territory. This evaluation is carried out by the Commission for eligibility for phase I clinical trials (referred to in Article 5 of Presidential Decree no. 439 of 21 September 2001), operating at the Istituto Superiore di Sanità, which expresses its opinion in compliance with the principles of independence, transparency and scientific rigor.
It is then the task of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) to authorize or not the trial on the basis of the opinion of the aforementioned Commission.
The Proposers of a Phase I clinical trial must obtain an authorization from the competent Authority (in Italy, AIFA) and the favorable opinion of the Coordinating Ethics Committee of the clinical trial.
The Commission expresses opinions on requests for eligibility for phase I clinical trials on the national territory, supporting, in the manner provided for by the Decree of the Ministry of Health of 27 April 2015, the competent Authority for the issuance of the authorization or denial measure. The Commission is appointed by Ministerial Decree and remains in office for 3 years.
The Commission avails itself of the contribution of the experts appointed by the President of the Istituto Superiore di Sanità and the support of a Technical-Scientific Secretariat and Administrative Secretariat.
Composition of the Commission and Secretariats
The Commission is appointed by Ministerial Decree and remains in office for 3 years. It avails itself of the contribution of the experts appointed by the President of the Istituto Superiore di Sanità and the support of the Technical Scientific Secretariat and the Administrative Secretariat.
Members by right
President of the Commission: The President pro tempore of the Istituto Superiore di Sanità or his/her delegate
Director General pro tempore of the Italian Medicines Agency or his/her delegate
Internal and external experts
Prof. Carla Cannizzaro (University of Palermo)
Prof. Pietro Merli (Bambino Gesù Hospital - Rome)
Prof. Francesco Perrone (National Cancer Institute IRCCS Pascale Foundation - Naples)
Dr. Paolo Foggi (Drug Innovation and Strategy Sector - AIFA)
Dr. Mauro Biffoni (Department of Oncology and Molecular Medicine - ISS)
Dr. Patrizia Popoli (National Center for Research and Preclinical and Clinical Evaluation of Drugs - ISS)
Secretary of the Commission: Dr. Maria Francesca Cometa (National Center for Research and Preclinical and Clinical Evaluation of Drugs - ISS)
Technical-Scientific Secretariat: Dr. Bianca Barletta, Dr. Cinzia Butteroni, Dr. Maria Francesca Cometa, Dr. Gabriella Di Felice, Dr. Andrea Matteucci (National Center for Research and Preclinical and Clinical Evaluation of Drugs, ISS)
Administrative Secretariat: Dr. Marina Franco, Mrs. Laura Parisi, Mrs. Antonella Simonelli, Mrs. Anna Tobelli, Mrs. Maria Teresa Volpe, Dr. Alessandra De Dominicis, Dr. Alessandra Lepri (National Center for Research and Preclinical and Clinical Evaluation of Drugs, ISS)
Dipartimenti/Centri/ServiziNational center for drug research and evaluation
SCF1 - Sperimentazione Clinica Fase IChi siamo
TopicsMedicines, vaccines and advanced therapies