Phase I clinical trials

Phase I clinical trials

Responsible: Dr. Maria Francesca Cometa
phone: (+39) 06 4990 2880

Phase I clinical trials typically represent the transition from preclinical trials (in vitro and / or on animals) to the first administration of a drug in humans and, therefore, constitutes a particularly critical moment in the development of a new drug.

Due to the complexity of this step, since 1973 the Italian legislation has entrusted the Italian National Institute of Health (ISS) with the technical-scientific evaluation of the authorization requests submitted by proposers on the national territory. This assessment is carried out by the Commission for admissibility to the Phase I clinical trial (pursuant to art. 5 of Presidential Decree 21 September 2001, n.439), operating at the Italian National Institute of Health, which expresses its opinion in the respect for the principles of independence, transparency and scientific rigor.

It is then the task of the Italian Medicines Agency (AIFA) to authorize or not authorize the experimentation based on the opinion of the aforementioned Commission.

The Commission avails itself of the contribution of experts appointed by the President of the Italian National Institute of Health and the support of a technical, scientific (STSF-1) and administrative (SA) secretariat.

Composition of the current Commission (Art. 2, DM 12.02.2018) and of the secretariats

Members by right

  • President of the Commission: The pro tempore President of the Italian National Institute of Health or his delegate
  • General manager pro tempore of the Italian Medicines Agency or his delegate


  • Prof. Carla Cannizzaro (University of Palermo)
  • Prof. Paolo Maria Rossini (Catholic University of the Sacred Heart-Rome)
  • Prof. Armando Santoro (Cancer Center-IRCCS Humanitas Clinical Institute- Rozzano-MI)
  • Dr. Paolo Foggi (Innovation and Drug Strategy Sector-AIFA)
  • Dr. Ugo Testa (Department of oncology and molecular medicine, ISS);
  • Dr. Patrizia Popoli (National center for drug research and evaluation, ISS)

Commission Secretary: Dr. Maria Francesca Cometa (National center for drug research and evaluation, ISS)

Technical scientific secretary (STS-F1): Dr. Cinzia Butteroni, Dr. Maria Francesca Cometa, Dr. Gabriella Di Felice, Dr. Fiorella Malchiodi Albedi, Dr. Andrea Matteucci, Dr. Lucia Palmisano (National Research Center and preclinical and clinical evaluation of drugs, ISS)

Administrative Secretariat (SA): Dr. Marina Franco, Dr. Paola Lorenzini, Mrs. Laura Parisi, Mrs. Antonella Simonelli, Mrs. Anna Tobelli, Mrs. Maria Teresa Volpe (National Center for Preclinical Research and Evaluation and drug clinic, ISS).