How are we doing with the implementation of the European regulation on clinical trials of drugs, to which Italy is also called upon to adapt? Not good, despite the short time to catch up. This is why the Federation of Italian Cooperative Oncology Groups (Ficog) and the Italian Association of Medical Oncology (Aiom) are asking to push the accelerator “to have all the implementing measures and decrees, gathered within a unique planning “. The appeal comes from the national conference “Cooperative Groups in Oncology. The new challenges of independent research ”by the two scientific societies, which was held today in Rome. “The European Regulation aims to standardize and simplify clinical research in the Old Continent but, at the same time, guarantee the quality of studies and the safety of patients.”, Explains Carmine Pinto, President of the federation that brings together the 17 cooperative groups in Oncology that promote in our country, no-profit clinical research: “In Italy, at the moment, funding and resources are still limited, with a fragmentation and lack of coordination between projects”.
The decline in independent trials
The price to pay is the loss of efficiency also for research, especially independent research, a very evident phenomenon in oncological experiments. First of all, it is necessary to accelerate the identification of the characteristics of the centers that have to carry out research in the Peninsula, according to Pinto. FICOG has in fact produced a technical document to define specific parameters, together with FADOI (Federation of Associations of Hospital Internists), GIMEMA (Italian Group of Adult Hematological Diseases) and GIDM (Italian Data Manager Group). The document will be made available to the Italian Medicines Agency. “We are also awaiting responses for the reorganization of the Ethics Committees”, continues Pinto: “Their reduction to 40 territorial committees has already been approved, as well as the four national committees, in which it is necessary, due to the impact and the volume of oncological research, the presence of medical oncologists, considering that 40% of all clinical studies conducted in Italy concern anti-tumor treatments “.
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In the conference, ample space was given to the state of the art of the Regional Oncological Networks, which are also very important for clinical research, because they can promote and facilitate experimentation from a planning, management and administrative point of view. “We must finally arrive at defining the professional figure of the Clinical Research Coordinators and their stabilization, now possible only in the Scientific Hospitalization and Care Institutes (IRCCS), but we well know that a large part of clinical studies are conducted in hospitals and in universities “.
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Finally, it will be essential to update the training system in order to be able to count on new necessary professional figures, and to promote correct information on the usefulness of clinical research in our country. “Precisely for this reason, like Ficog – concludes Pinto – we have decided to launch the campaign“ Do you know how important it is? ”, Which will also be presented at the next Asco conference”.