Adnkronos Rome, November 8 (Adnkronos Salute) – In Italy, over the past 15 years (2009-2023), non-profit clinical trials, i.e., those not sponsored by industry, have decreased by 57%. In 2009, they accounted for 40,3% of all trials, and they fell to 17,3% in 2023. These data highlight the crisis in independent clinical research, in which oncology plays a predominant role.
However, resources and personnel are lacking. Essential professional roles must be established, such as clinical research coordinators, research nurses, biostatisticians, and budget and contract review experts. And the bureaucratic constraints that delay the start of scientific work must be eliminated. A change of pace is therefore needed to support and revitalize independent research. This is the request of oncologists who, at the 27th National Congress of AIOM (Italian Association of Medical Oncology) underway in Rome, are devoting considerable attention to nonprofit studies.
"In 2023, 611 clinical trials were authorized in Italy, and 212, or 34,7% of the total, involved cancer, the area with the highest concentration of authorized trials," says Francesco Perrone, president of AIOM. "In 2023, independent studies began to grow again, reaching 106 compared to 98 the previous year. But this is not enough. The potential of oncology research in Italy is significant, and our studies have the potential to change clinical practice, but more resources are needed. Funding in this sector has always been understaffed in our country, which ranks among the lowest in Europe in terms of public support. It is essential to implement a national plan that also includes increased staffing." Perrone notes that "it is important for independent research to explore new models for planning and managing clinical trials, leveraging the opportunities afforded by digital tools as much as possible. Clinical trial management is becoming increasingly complex," he observes, "and requires multidisciplinary skills. It is essential to have diverse professional roles. In particular, clinical research coordinators, i.e., data managers, are crucial because they are responsible for managing data within trials. A regulatory gap prevents them from being structured within teams, limiting their employment to freelance contracts, scholarships, and research grants. Unfortunately, we are witnessing the migration of qualified personnel to pharmaceutical companies and contract research organizations."
In 2024, an estimated 390.100 new cancer diagnoses were recorded in Italy. The tumors receiving the greatest number of trials are gastrointestinal, breast, thoracic, urological, and gynecological. "The Cassandra study, entirely funded by five patient organizations, demonstrates the value of independent clinical research," emphasizes Michele Reni, Director of Medical Oncology at the IRCCS San Raffaele Hospital in Milan. "Seventeen Italian centers participated, enrolling 260 patients with pancreatic ductal adenocarcinoma who were candidates for surgery. The standard preoperative chemotherapy regimen with mFolfirinox, previously considered the most effective, was compared with Paxg, a combination of chemotherapy drugs developed from a previous independent Italian study. The results showed that survival without adverse events—that is, progression, recurrence, inoperability, and death—was significantly improved in patients treated with Paxg. This opens up a concrete opportunity to improve the survival of patients with one of the most aggressive cancers. This achievement is possible thanks to the collaboration between the world of science and civil society."
"Oncology is one of the clinical areas in which patient associations have achieved a high level of expertise, with an active and recognized role in decision-making processes," emphasizes Flori Degrassi, president of Andos (National Association of Women Who Have Had Breast Surgery). "Patient associations can also prove to be a valuable ally in research, as they can facilitate patient recruitment into trials. We must overcome the existing prejudices regarding participation in clinical trials, which provide access to innovative therapies, even years before approval, and contribute to the availability of treatment for other patients affected by the same cancer. Furthermore, also in light of my experience as director general of a local health authority (ASL), I believe that the results obtained through independent studies should serve as a benchmark for evaluating the work of directors general."
"Following the registration trials of new drugs, many questions remain unanswered regarding the best use of therapies in daily clinical practice," explains Giuseppe Procopio, president-elect of Ficog (Federation of Italian Cooperative Oncology Groups). "These questions require the initiative of the academic community. The areas of non-profit studies primarily concern addressing unmet needs, which are not a priority for industry-sponsored research, and evaluating the efficacy and safety of a treatment in real-world clinical practice, on a larger population and with longer-term follow-up. Non-sponsored studies also address the definition of the best 'place in therapy,' that is, the best use of drugs, defining therapeutic strategies for combinations, sequential use, and combinations with other types of treatment."
"We are asking AIFA, the Italian Medicines Agency, for support, both in terms of funding and regulatory support, to facilitate the implementation of independent studies," Perrone continues. "From 2005 to 2023, AIFA has made approximately €160 million available for independent studies, enabling work to be conducted in relevant areas. Overall, to date, nearly 300 clinical studies have been funded by the regulatory agency. Last year, three AIFA calls for independent research in non-small cell lung cancer, renal cell carcinoma, and hepatocellular carcinoma were awarded. The funding totaled €7.5 million, a significant step forward in supporting non-profit studies in oncology. It is very important," he concludes, "that other calls for independent research be promoted as well, which, if supported, can achieve the triple mission of improving clinical practice, increasing awareness of new drugs, and supporting reimbursement policies."