Tumors: first census of the 149 research centers in Italy

Tumors: first census of the 149 research centers in Italy

The life of patients with a tumor is lengthened, and the extra years gained are spent with good quality. We often take this into account by dutifully mentioning that all of this is possible thanks to scientific research. But who carries out the oncological trials? Where are they carried out and with what resources are available? The answer 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 real census of the structures that carry out trials on tumors in our country, presented to the Ministry of Health today, the date on which the first National Day of Cooperative Groups for Oncology Research is celebrated, promoted by Ficog, an event that will be held every year to raise citizens' awareness of the importance of trials independent clinicians.

The value of Italian scientific research

The current Minister of Health underlines the value of scientific research in our country, Horace Schillaci, who writes in the preface of the book: “Italian scientific production is at the forefront in many areas and our Schools have received many awards at an international level. Never before have we been aware of the excellence of Italian researchers and, for years, in Italy, cooperative groups have been active which have the precise task of developing clinical research in the various sectors and have produced works that have become milestones in Oncology Medical worldwide. As a doctor and Minister of Health, I believe it is essential to place research at the center of health policies and the activities of the National Health Service, in order to relaunch health care as a whole and ensure the best therapeutic opportunities for citizens".

The photograph of oncological research centres

In Italy there are 149 centers surveyed that conduct clinical research in oncology. 91% have an in-house accredited radiology, 76% have a pathological anatomy and 68% have a molecular biology laboratory, which is very important for the central role of precision medicine. Almost half of the centers (69) carry out a good number of trials each year, between 10 and 40, and 29 structures exceed 40 trials. "With this volume we offer institutions a concrete tool for identifying centers that can meet the new requirements established by the European Regulation 536 of 2014 on clinical trials", he says Carmine Pinto, president Fig. “The studies conducted in Italy have changed clinical practice at national and international level in different types of tumors, leading to the modification of guidelines and recommendations”.

Insufficient staff and infrastructure

However, there are also some serious critical issues in the availability of personnel and a solid infrastructure, essential for guaranteeing the quality of the studies: 67% (100 centres) do not have a bioinformatics specialist, 48% (72) cannot count on the support statistical. And there are too few structured clinical research coordinators (data managers), researchers and research nurses. The IT structures available are also lacking, in fact only 40% can use a data processing system. Furthermore, there are strong territorial differences, because over half of the research structures in oncology (78 out of 149) are located in the North, 38 in the Center and only 33 in the South. "Public funding in this sector has always been undersized in our country. 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”, continues Pinto.

The National Network for Clinical Research

The tumors on which the greatest number of trials are concentrated are those of the breast, gastro-intestinal, thoracic, urological and gynecological. As far as territorial diffusion is concerned, the Region that boasts the most structures is Lombardy (28), followed by Lazio (18), Piedmont (15), Veneto (14) and Emilia-Romagna (13). “The creation of the National Network for Clinical Research, which is also essential for attracting private investment, can no longer be postponed. Programming must also be declined at the local level, with the full establishment of the Regional Oncological Networks, which can promote and facilitate experimentation from a planning, managerial and administrative point of view. In this way the territorial differences, which see most of the centers in the North, can be bridged", underlines President Ficog.

Specific skills

Almost 40% of the trials conducted in our country concern oncology. 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, experts in budget and contract review. In particular, clinical research coordinators are fundamental figures, because they are responsible for managing data within trials", he says Saverio Cinieri, president Aiom. "Where they are present, there is a significant increase in the performance of the center, which translates into the enrollment of patients, high quality standards, the safeguarding of the well-being of people in the studies and the optimization of processes".

The migration of experts

Unfortunately, a regulatory vacuum does not allow them to be structured within teams, limiting their use with freelance contracts, scholarships and research grants. “We are witnessing a constant migration of experienced and qualified personnel to pharmaceutical companies and contract research organisations,” continues Cinieri. "It is essential to identify, with the help of the institutions, a legislative path for the recognition of data managers".

Faster times with European legislation

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 adapted to EU legislation, thanks to the four decrees signed by the Minister of Health (published in the Official Gazette No. 31 of 7 February 2023). “The European Regulation represents an excellent opportunity to overcome the current critical issues – adds Pinto. “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 evaluation time of a study by the Ethics Committee is, in most cases, 4-8 weeks. The average time required to sign the contract is also between one and two months. The European Regulation will speed up the authorization procedures and eliminate bureaucratic constraints and often heterogeneous and redundant requests for documentation".

The role of patients

Among the most recent innovations in the field of clinical research is the recognized role of patient associations in the activities promoted by the European Commission. 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 the decision-making processes: from trials, to tenders, to ethics committees, to programming. “Considering that clinical research must be 'patient centred' - he says Francis DeLorenzo, president Favo (Italian Federation of Oncology Volunteer Associations) - the motion commits the Executive to include in national research tenders what has already been foreseen by the European Commission, i.e. to consider the collaboration of patient associations in co-planning and management as an added value of projects. So far the associations have collaborated because they are involved by oncologists, whom we thank, but a specific legislative initiative is needed ".

The awareness campaign

Today the spot is also presented at the Ministry of Health, which is part of the awareness campaign "Do you know how important it is?" and which will be disseminated on social networks and on TV. “It is essential to promote correct information and participation – concludes Pinto. “We address citizens directly to communicate the value of research and its essential role for progress in knowledge and in tumor control and treatment strategies. Thanks mainly to research, today 60% of patients are alive 5 years after diagnosis and one million people can be considered cured".



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