Phase I studies: a test bench for Italian clinical research

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.

Access to Early Phase Clinical Trials at the Time of the Covid-19 Pandemic: An Italian Survey

“…Nevertheless, we noted that, although this aptitude is rather diffuse among physicians, the percentage of patients usually referred to early phase clinical trial units is limited with only 12.6% of responders referring more than 10% of their patients. Numerous reasons could explicate these data, but one of the most important reasons is the asymmetric distribution of Phase I centres on national territories, and the ongoing phases I study concentrated in a few locations (15,16). Furthermore, in a classification considering the phase I trials conducted worldwide between 1999 and 2020, Italy ranks only 14 th position, following other similar European countries (i.e., Germany, France, Spain, and the Netherlands) (17).…”

Mind the gap with Europe. Why public interest cannot be a good reason to perform observational and epidemiological research?

“…12 This issue becomes incredibly apparent when talking about studies other than interventional studies, for which no one will ever want to go beyond the proper consent of data subject, such as when we refer to observational/epidemiological research that can be considered with a mere secondary use of data. 13…”

European Clinical Trials Regulation 536/2014: Concerns and Perspectives of a Member State

“…It will be interesting to understand, and perhaps the delay in identification is also due this issue, which requirements will be able to guarantee an adequate quality for clinical studies in profoundly different therapeutic areas, without excluding any bodies that might have an important role in scientific advancements in specific fields. It will perhaps be important not to repeat some mistakes made with phase I studies, which in fact in many cases have required considerable efforts greater than the actual needs for the conduct of clinical trials and a large investment both in economic and non-economic terms, perhaps also incompatible with the current possibilities of the National Health System (22,23).…”