Phase I studies: a test bench for Italian clinical research
| Autor: | F. Arizio, Francesca Vannini, Alessandro Di Costanzo, Rosita Cenna, Gianna Tabaro, Giuseppe Procopio, Veronica Franchina, Stefania Gori, Celeste Cagnazzo, Oriana Nanni |
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| Rok vydání: | 2019 |
| Předmět: |
Cancer Research
Test bench Computer science media_common.quotation_subject Phase (waves) clinical research Phase I studies quality requirements self-certification Humans Italy Medical Oncology Neoplasms Surveys and Questionnaires Clinical Trials Phase I as Topic Phase I as Topic 03 medical and health sciences 0302 clinical medicine Quality (business) Clinical Trials 030212 general & internal medicine media_common General Medicine Reliability engineering Oncology Order (business) 030220 oncology & carcinogenesis |
| Zdroj: | Tumori. 106(4) |
| ISSN: | 2038-2529 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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