UNIVERSITY UNIVERSITYOFOFTORINO TORINO––DEPARTMENT DEPARTMENTOF OFONCOLOGY ONCOLOGY Perspectives from the Italian Association of Medical Oncology (AIOM) Massimo Di Maio Department of Oncology, University of Turin AIOM National board, 2013-2015 [email protected] UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY Clinical research is crucial in oncology La sperimentazione clinica dei medicinali in Italia 13° rapporto nazionale - 2014 UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY La sperimentazione clinica dei medicinali in Italia 13° rapporto nazionale - 2014 UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY La sperimentazione clinica dei medicinali in Italia 13° rapporto nazionale - 2014 UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM and clinical research • AIOM strongly supports clinical research, that has an essential role in the development of new therapeutic approaches for cancer patients. • In the last decades, non-profit, academic research has produced important results in Italy, despite financial and regulatory difficulties that have challenged the conduction of clinical trials in this field. • AIOM believes that non-profit research should be supported and encouraged. UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM and clinical research • AIOM strongly supports clinical research, that has an essential role in the development of new therapeutic approaches for cancer patients. • In the last decades, non-profit, academic research has produced important results in Italy, despite financial and regulatory difficulties that have challenged the conduction of clinical trials in this field. • AIOM believes that non-profit research should be supported and encouraged. UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY FICOG In april 2015, under the auspices of AIOM, a federation of Italian cooperative groups for clinical research in oncology (FICOG) has been founded, with the aim of implementing cooperative, multicentre trials both at a national and an international level. Courtesy of Francesco Di Costanzo UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY Courtesy of Francesco Di Costanzo UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY Courtesy of Francesco Di Costanzo UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY FICOG: aims • To implement clinical research in oncology; • To define a procedure for accreditation of adhering Groups; • To support the accreditation of professional figures involved in clinical research; • To promote cooperation with International groups; • To promote cooperation with pharma. UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM and clinical research A few months ago, AIOM (in particular, the Working Group dedicated to Clinical research) published the document “Minimum requirements for clinical research in Italy” (“La ricerca clinica in Italia: requisiti minimi necessari”). The document is publicly available on the AIOM website: http://www.aiom.it/area+pubblica/area+medica/p rodotti+scientifici/working+group/Ricerca+clinica/ 1,4464,1, UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM “minimum requirements for clinical research in Italy” [<] Minimum requirements to consider an oncology center idoneous to perform clinical trials are, among others, the presence of staff (not only physicians) with adequate and specific formation in clinical research. [<] UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM “minimum requirements for clinical research in Italy” Human resources: [<] • Data managers / Clinical research coordinators (CRC) • Research nurses • Research pharmacists [<] UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM “minimum requirements for clinical research in Italy” UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM supports all professional figures involved in clinical research • Unfortunately, despite clinical research coordinators / data managers are part of the research staff in many Italian institutions, they are not formally employed as a specific professional figure. • In last years, AIOM and other associations, together with GIDM (Gruppo Italiano Data Manager) are lobbying for the formal recognition of CRC as a professional figure within the National Health System. UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM supports all professional figures involved in clinical research In order to promote the cooperation among the different professional figures involved in clinical research, AIOM has recently instituted a Working Group dedicated to Clinical research coordinators. – Scientific sessions during meetings – Surveys – “Job description” document UNIVERSITY OF TORINO – DEPARTMENT OF ONCOLOGY AIOM and clinical research Clinical research is a VALUE: • For patients • For oncologists • For institutions UNIVERSITY UNIVERSITYOFOFTORINO TORINO––DEPARTMENT DEPARTMENTOF OFONCOLOGY ONCOLOGY Thanks for your attention! Massimo Di Maio Department of Oncology, University of Turin AIOM National board, 2013-2015 [email protected]