Il ruolo del farmacista ospedaliero nell’evoluzione dei trial clinici condotti presso l’AOU “Città della Salute e della Scienza” di Torino
Alessandra Varese, Martina Tonelli, Matilde Scaldaferri, Francesco Cattel
Introduction: The “UFA – Unità Farmaci Antiblastici” at the “Città della Salute e della Scienza di Torino – Presidio Molinette” is involved in the management of several profit and non-profit clinical trials, increasingly based on new molecules or therapeutic associations that are administered intravenously or subcutaneously. The aim of this study is to evaluate the trend of clinical trials and to emphasize the role of the hospital pharmacist.
Materials and Methods: Considering the two Haematology departments of the hospital and the use of Log80 software, we collected quality and quantitative data in a dedicate database which contains the amount of trials approved, the type and the phase of the trials, the drugs used, the number of patients enrolled and the date of authorization by Ethical Committee.
Results: Since 2011 to Aug. 2016, 40 profit and 18 non-profit trials were authorized; 329 patients were enrolled, including 160 patients with Multiple Myeloma, 101 patients with non-Hodgkin’s Lymphoma of various histology, 23 patients with Acute Lymphoblastic Leukaemia and Chronic Lymphocytic Leukaemia respectively. The largest number of trials were for Multiple Myeloma and Non Hodgkin Lymphoma. As for the drugs used, 15.50% of patients were treated with carfilzomib and 12.16 % with bortezomib. Twenty-five out of the total 58 were phase 2 studies.
Conclusions: The data show that clinical research is constantly evolving, allowing the study of new therapies in onco-hematology and subsequently the increase in the number of clinical trials conducted in highly-specialized centers. In according to this scenario, the hospital pharmacist plays an important role in the management and monitoring of clinical trials. The development of new organizational procedures and cooperation among all professionals involved are required to ensure adherence to Italian Norme di Buona Preparazione.
Key words: clinical trials, profit, no-profit, hospital pharmacist, drugs, oncology