Phase I studies: a test bench for Italian clinical research

Celeste Cagnazzo, Oriana Nanni, Francesca Arizio, Veronica Franchina, Rosita Cenna, Gianna Tabaro, Francesca Vannini, Giuseppe Procopio, Stefania Gori, Alessandro Di Costanzo

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures. METHODS: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website. RESULTS: Questionnaires from 24 institutions were collected, 9 previously inspected by competent authorities. All surveyed structures are certified to conduct profit studies and 1 is authorized to include healthy volunteers; 15 units implemented a Clinical Trial Quality Team in order to conduct nonprofit studies. At the time of data collection, a total of 398 proposals for phase I trials have been received, more than 50% coming from 3 institutes. A total of 144 phase I studies were active, with a median of 2.5 (Q1-Q3=0-6) studies for each center and asymmetric distribution of proposals. CONCLUSION: The considerable number of proposals received from the interviewed centers indicates that Italy plays an important role in the international pharmaceutical scene, despite bureaucratic procedures that threaten exclusion from decision-making. The AIFA Determination will be an important opportunity to acquire a competitive working approach.
Original languageEnglish
Pages (from-to)epub
Number of pages6
JournalTumori
DOIs
Publication statusPublished - Aug 9 2019

Keywords

  • Phase I studies
  • clinical research
  • quality
  • requirements
  • self-certification

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