We have 149 Centers, more than half in the North, many conducting a good number of trials every year. State-of-the-art studios, but lack of staff and funding. The photograph taken from the first yearbook on the subject
It is thanks to scientific research if in recent years the number of deaths due to cancer has decreased and the percentage of people who recover has increased or who live for a long time with a disease that is slowed down by treatment. Search both of new therapies (more valid and less toxic) both of prevention and early diagnosis strategies more effective. So today 60% of cancer patients are alive five years after diagnosis and one million compatriots can be considered cured. And if scientific research is conducted by doctors and scientists all over the world, important progress has also been made thanks to brilliant Italian professionals: the studies conducted in our country, in fact, have changed clinical practice in different types of tumors, leading to the modification of global guidelines and recommendations. Will it continue to be like this in the future? Will cancer patients continue to be able to take advantage of the opportunity to participate in trials with cutting-edge treatments? And how is it oncology research in our country? Not very well, is the answer that comes from the first «Yearbook of Oncological Research Centers in Italy», promoted by the Federation of Italian Cooperative Oncology Groups (FICOG) and by the Italian Association of Medical Oncology (Aiom), a veritable census of the structures that carry out trials on tumors in our countrypresented to the Ministry of Health.
The photograph taken from the volume
In Italy there are 149 Centers surveyed conducting clinical research in oncology. Almost half (69) carry out a good number of trials each year, between 10 and 40, and 29 facilities exceed 40 trials. However, strong critical issues remain in the availability of personnel and a solid infrastructure, essential to guarantee the quality of the studies: 67% (100 centres) do not have a bioinformatics specialist, 48% (72) cannot count on statistical support. AND there are too few clinical research coordinators structured (data managers), researchers and research nurses. They are also lacking IT structures available, in fact only 40% can use a data processing system. Furthermore there are strong territorial differencesbecause over half of the oncology research facilities (78 out of 149) are located in the North, 38 in the Center and only 33 in the South. Finally, 91% of the Centers have a local accredited radiology, 76% have a pathological anatomy and 68% have a molecular biology laboratory, a very important aspect for the central role of precision medicine. If thanks to the four decrees signed by the Minister of Health Orazio Schillaci on January 30, our country has finally adapted to European legislation (issued nine years ago and from which we risked being excluded by missing a crucially important train), there is still a lot to do to continue offering the best to patients and remain competitive on the international scene.
Improvements with the new EU regulation
“Italian scientific production is at the forefront in many areas and our schools have received many awards at an international level – comments the Minister of Health, Horace Schillaci, in the preface of the book -. Adequately supported through research support initiatives, medical oncology can be a driving force for not only scientific, but also economic and social development. Never before have we been aware of the excellence of Italian researchers and they have been active in Italy for years cooperative groups which have precisely the task of developing clinical research in the various sectors and have produced works that have become milestones of medical oncology worldwide. The European Regulation 536 of 2014 harmonized the evaluation and authorization process of a clinical study conducted in several Member States. And Italy has finally complied with Community legislation, thanks to the four decrees signed by the Minister of Health (published in the Official Gazette no. 31 of 7 February). «The European Regulation represents an excellent opportunity to overcome the current critical issues – he underlines Carmine Pinto, president Figog -. It standardizes and simplifies clinical research but, at the same time, ensures the quality of studies and patient participation. From our census it emerges that the average time for evaluation of a study by the Ethics Committee is, in most cases (68%), 4-8 weeks. The average time required to sign the contract is also between one and two months. The new rules will speed up the authorization procedures and eliminate bureaucratic constraints and often heterogeneous and redundant documentation requests».
Public funding is lacking
“With this volume we offer institutions a concrete tool for identifying the Centers that can meet the new requirements established by the European Regulation 536 of 2014 on clinical trials – explains Carmine Pinto -. But personnel, digital infrastructures, economic and organizational resources are needed. “Non-profit” studies, ie studies not promoted directly by the pharmaceutical industry but by public bodies or non-profit research organizations, are in fact declining and public funding has always been insufficient. We are at the last places in Europe for financing. If research is central to development and innovation, then it is essential to define and implement a single strategy and a national plan. The realization of the can no longer be postponed National network for clinical research, also essential for attracting private investment. The programming must also be declined at the local level, with the full establishment of regional oncological networks, which can promote and facilitate experimentation from a planning, managerial and administrative point of view. In this way territorial differences can be bridgedwhich see most of the Centers in the North».
Data managers are needed (with adequate employment contracts)
“Almost 40% of the trials conducted in our country concern oncology,” he says Saverio Cinieri, president Aiom -. The management of clinical trials is becoming increasingly complex and requires specific and multidisciplinary skills. It is important to have different professional figures, such as clinical research coordinators, i.e. data managers, research nurses, biostatisticians, budget and contract review experts. In particular, clinical research coordinators are fundamental figures, because they are responsible for managing data within the trials. Where they are present, there is an important increase in the Centre’s performance, which translates into the enrollment of patients, high quality standards, safeguarding the well-being of people in the studies and optimizing processes». However a regulatory vacuum does not allow them to be structured within teams, limiting their use with freelance contracts, scholarships and research grants. «We are therefore witnessing a constant migration of expert and qualified personnel towards pharmaceutical companies and contract research organizations – continues Cinieri -. It is essential to identify, with the help of the institutions, a legislative path for the recognition of data managers».
Why it is useful to participate in the trials
In 2022, in Italy, they were estimated 390,700 new cancer diagnoses. In two years, the increase was 14,100 cases. From a strictly personal point of view, participating in a clinical trial allows an individual cancer patient to have early access to an innovative drug, which could enter the market even after several years. In a broader social vision, however, participation allows each patient to contribute their own experience to the advancement of knowledge, improving the expectations of future patients. The Region that boasts the most structures is the Lombardy (28), followed by Lazio (18), Piedmont (15), Veneto (14) ed Emilia Romagna (13). The tumors on which the greatest number of trials are concentrated are those mammary, gastro-intestinal, thoracic, urological and gynecological. “The direct participation of patient associations in the research activities promoted by the European Commission is now a reality,” he concludes Francis DeLorenzo, president of the Italian federation of voluntary associations in oncology (Favo) —. Furthermore, the unanimous approval by the Chamber of Deputies of a motion in which the Government is recommended to involve and listen to patients continuously from the early stages of decision-making processes: from trials, to competitions, to ethics committees, to programming. Considering that clinical research must be “patient-centred”, the motion commits the Executive to include in national research tenders what has already been foreseen by the European Commission, i.e. consider the collaboration of patient associations in the co-planning and project management as an added value. The legislator, therefore, must adapt the legislation to what is established at European level”.
March 14, 2023 (change March 14, 2023 | 12:57)
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