Thanks to research and prevention, today in Italy 60% of patients are alive five years after diagnosis of cancer and one million people can be considered cured. These two numbers are enough to make clear how necessary clinical research is, even more so when it is independent, conducted by courageous researchers who very often spend the best years of their lives locked in the laboratory in search of authentic, impartial and unconditional data that can bring to innovative therapies that place public health above all other interests. In Italy there are 183 oncology research centers that ‘produce’ results that do not disappoint us at all in comparison with other countries in the world, but it is worrying that only 20% of studies on new molecules are non-profit. The second edition of the Yearbook of Oncology Research Centers in Italy, promoted by the Federation of Italian Cooperative Oncology Groups (Ficog) and the Italian Association of Medical Oncology (Aiom), a true and own census of the structures that carry out cancer trials in our country, presented today to the Ministry of Health, on the occasion of the National Day of Cooperative Groups for Oncology Research, promoted by Ficog every year to raise citizens’ awareness of the importance of independent clinical trials .
Focus on research as a country system
In 2023, in Italy, an estimated 395,000 new cancer diagnoses were made. The tumors on which the greatest number of trials are concentrated are gastrointestinal, breast, thoracic, urological and gynecological ones. “Thanks to research and prevention, today in Italy one million people can be considered recovered”, explains the Minister of Health, Orazio Schillaci, in the preface of the book. “These results instill confidence in us and constitute an incentive to invest strongly in scientific research to ensure that patients can access innovative and safe therapies more quickly, as well as to guarantee greater competitiveness of Italy on a global level. With the National Oncology Plan, which we have adopted and financed, we support research, prevention and strengthening the capacity to take charge, care and assist cancer patients. Furthermore, to the funding for research supported by the Ministry of Health, also with the calls for targeted research, are added investments that make use of the resources of the National Recovery and Resilience Plan”.
The photography of the research centers
There are 183 centers registered that conduct clinical research in oncology in Italy. Almost 50% are located in the North (90), the rest in the Center (44 centers) and the South (49 centers). Around a third of the structures (36%, equal to 66 centres) carry out more than 20 trials per year, 12% over 60. The quality of the studies is also guaranteed by the presence, in 72% of cases, of standard operating procedures ( SOP, Standard Operating Procedure), i.e. checklists that allow you to produce high-level results. “The Yearbook of Oncology Research Centers in Italy analyzes the characteristics of 183 centres, 23% more than last year’s edition, thus contributing to providing an even more realistic analysis of the state of cancer research in our country “, explains Evaristo Maiello, president of Ficog. 80-90% of the centers have accredited radiology on site, are equipped with an anatomical pathology, an accredited analysis laboratory, an on-site molecular biology laboratory and have a dedicated administrative office”.
Oncology, the Pezcoller Women in Cancer Research Award goes to Maria Rescigno
by Irma D’Aria
Independent research is declining
What worries oncologists and researchers above all is a fact that also emerged from the Report of the Italian Medicines Agency (AIFA) on Clinical Trials: “There is a clear reduction in the space for independent research – continues Maiello. In one year (2021-2022 ), in our country, clinical trials not sponsored by the pharmaceutical industry have gone from 22.6% to 15% of the total. A decrease of over 7% in 12 months alone, which risks greatly impoverishing the research system profit in Italy, especially in very critical areas such as oncology”.
Oncology research, the “Gianni Bonadonna” Award goes to Francesco Cognetti
Staff shortages and digitalisation in slow motion
Another problem that has been dragging on for years also remains open, namely the lack of resources and personnel: 68% (124 centers) lack a bioinformatician and 49% (89) cannot count on statistical support. Indispensable professional figures must be structured, such as clinical research coordinators (data managers), research nurses, biostatisticians, budget and contract review experts. And digitalisation, which allows trials to be speeded up and simplified, is still scarce: only 43% use a data processing system and 37% an electronic medical record. A change of pace is needed to support academic research, also because, today in Italy, only 20% of studies on new molecules against cancer are non-profit. 21% of the structures are included in AIFA centers accredited for Phase I, which includes the most complex studies because they involve stringent requirements, dedicated operational procedures and certification by the regulatory body.
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by Irma D’Aria
The added value of independent clinical research
The potential of oncology research in Italy is also underlined Francesco Perronepresident of Aiom: “Regulatory trials are comparable to ‘snapshots’ on the efficacy and safety of new drugs. However, just like in a snapshot, what happens before and after the shot may not be in focus. The intrinsic limitations of registration studies do not allow us to optimize the use of a therapy throughout the patient’s therapeutic journey”, explains the Aiom president who adds: “Academic research can address these gaps and fulfill its mission of improving clinical practice , but a leap in quality is necessary. Studies must be planned that do not restrict attention to the efficacy and toxicity of a single drug or a single combination of drugs in a delimited segment of the natural history of the disease, but look at the entire path of patient care. In this sense, therapeutic sequence studies can optimize the effectiveness of available therapeutic options”.
The indications that come from patients
During the presentation event of the Yearbook, the added value of the active collaboration of patient associations in the promotion, planning and implementation of clinical trials was also discussed. “It is necessary to collect data from different sources to understand the needs of patients,” Elisabetta Iannelli, secretary Favo (Italian Federation of Volunteer Associations in Oncology). “For example, the Pros, the ‘patient-reported outcomes’, are indications coming directly from patients, without the intermediation or interpretation of health professionals or other subjects other than the patient himself. The Pros can concern symptoms , side effects, functional status, perceptions or other aspects of the therapy such as practicality and tolerability, but also other aspects that can strongly impact the quality of life as well as the curability of the disease. The indications contained in the PROs, detected through use of standardized and validated questionnaires, are of fundamental importance for evaluating the well-being of patients, their state of health and the management of therapies”.
#Cancer #research #studies #molecules #nonprofit
– 2024-03-29 03:02:36
