In one year (2021-2022), in Italy, independent clinical trials, i.e. not sponsored by the pharmaceutical industry, went from In one year (2021-2022), 22.6% to 15% of the total, and continues the declining trend for 2023. A decrease of over 7% in 12 months alone, which risks severely impoverishing our country’s non-profit research system, especially in very critical areas such as oncology. We need personnel, digital infrastructure, economic and organizational resources. Italy, with 99 researchers per 100 thousand inhabitants, is in fourth to last place in Europe and well below the continental average (equal to 143). There is a lack of data managers (a professional figure still widely destined for precariousness in our country today), research nurses, bioinformaticians, experts in budget and contract review. Public funding in this sector has always been undersized in Italy. For this reason, FICOG (Federation of Italian Cooperative Oncology Groups) asks the institutions for a decisive change of direction and an urgent meeting to outline a unitary, coordinated and shared strategy. A turning point that can only be achieved with the definition of a National Network for clinical research in oncology. The request comes from the XXV National Congress of the Italian Association of Medical Oncology (AIOM), underway in Rome.
40% of clinical trials involve oncology
“In 2022, 663 trials were authorized by the Italian Medicines Agency (AIFA) and almost 40% concerned oncology, a constant percentage in recent years – he explains Carmine Pinto, President of FICOG -. This is not the case for unsponsored academic research. The difficulties it faces are summarized in the decrease in independent studies: from 185 in 2021 (22.6% of the total) to 98 in 2022 (15%), and the trend is also decreasing for 2023. Despite having few resources available, the studies conducted in Italy have changed clinical practice at a national and international level in different types of tumors, leading to the modification of guidelines and recommendations. And Italian scientific works in the oncology field are among the most cited in the world. The drastic decline in independent research, however, requires a change of pace and unitary planning.”
What does the European Regulation provide?
European Regulation 536 of 2014 standardized the evaluation and authorization process of a clinical study conducted in multiple member states. “The community norm, to which our country has also adapted – he states Saverio CinieriPresident AIOM -, has established fundamental principles which concern the standardization and uniformity of processes and the authorization file, administrative simplification, certainty of evaluation and approval times, quality assurance and monitoring of clinical studies and participation and informed patient information”.
As required by the European Regulation, in the context of profit and non-profit multicentre studies it is necessary to identify the characteristics of the trials to define the level of complexity and the respective characteristics required for the centres, elements which must represent a reference for the Ethics Committees. When submitting a study, the promoter guarantees that the selected centers present the prerequisites that allow it to be carried out safely for patients and to maintain good quality in clinical procedures and data management.
“In 2022 – underlines Carmine Pinto – important differences were highlighted in the number of trials evaluated by the individual Ethics Committees, ranging from 10% of the total to 0.2%. These marked differences, which are attributable to structural and organizational problems, we hope will be resolved with the full implementation of the reform of the Ethics Committees. Academic research to adapt to the European Regulation is therefore penalized by the scarcity of economic, personnel and technological resources, by infrastructural criticalities and by the numerous and still unresolved administrative problems. Furthermore, some aspects still need to be defined, including the identification of the characteristics of the centers carrying out research, for which we have already made proposals to the institutions”. “FICOG together with FADOI, GIMEMA, ACC and GIDM had a meeting with representatives of the Ministry of Health last June – continues President Pinto -. Since then we have never been reconvened. We ask the institutions to be listened to as soon as possible, so as not to lose the great wealth of knowledge produced by independent trials: from studies on new therapies, to those on therapeutic sequences and adherence to treatments, on quality of life and the evaluation of effectiveness of new drugs in the post-registration phase”.
“FAVO considers the strengthening of academic research an absolute priority, because only through its clinical trials will it be possible to give urgent and adequate responses to the growing and still largely unsatisfied requests for studies and research that have the quality of life, the third pillar, as their most important objective. of the Mission on Cancer and subsequently fully implemented by the recently approved National Oncology Plan – he concludes Francesco De Lorenzo, President of FAVO (Italian Federation of Volunteer Associations in Oncology) -. The direct and active participation of Patients’ Associations in clinical trials and research projects has long been a reality in Europe, while in Italy only FAVO and UNIAMO obtained, last February, the approval of a motion unanimously by the Chamber of Deputies for the recognition of the right of patients to participate in research projects based on the centrality of cancer patients”.