“Italy risks losing the new train of clinical research which started on January 31, with the entry into force of the ‘Clinical Trial Information System’ (Ctis), the single European portal for trials”. This is the alarm raised by the Federation of Oncologists, Cardiologists and Hematologists (Foce). The Ctis, recalls the Federation, was established by the European Regulation 536 of 2014, establishing uniform rules to harmonize the evaluation and authorization process of a clinical study conducted in several Member States. A real revolution, which aims to attract more resources for research in Europe. But Italy has not yet adapted as required by the Regulation, the experts explain in an online press conference.
“Almost eight years have passed since the European Regulation was issued, but Italy – denounces Francesco Cognetti, President Foce – risks remaining in a one-year transition phase and it will be impossible to join the rest of the Continent when the system is already In this way – is the concern of Cognetti – we lose the advantages deriving from experiments that will see our country excluded and that provide for an identical enrollment and centralized evaluation for all member countries. With very serious consequences for our patients, who will not be able to take advantage of the great advantages of innovation produced by research “.
“On the basis of the latest available data, in 2019, 672 experiments were authorized in Italy, 516 for profit and 156 non-profit. And two thirds – remarks President Foce – altogether concern neoplasms, hematological and cardiovascular diseases, which among other things, they again produce two thirds of the annual mortality in our country. The Regulation marks an epochal change in clinical trials, passing from national management to coordination at European level. If our country, as wished several times by the Prime Minister Mario Draghi wants to regain international competitiveness – insists Cognetti – must include scientific research as a top priority on the government agenda “.
‘Research is the economic engine, investments of over 750 million per year’
Total public and private investments in this sector in Italy are equivalent to over 750 million euros per year – Foce recalls – of which 92% comes from funding from pharmaceutical companies for profit studies.
“Clinical research – explains Paolo Corradini, vice president Foce and president of the Italian Society of Hematology – is an engine of economic and social development, which can offer an important contribution to the recovery of the current health crisis. There are also positive repercussions for suppliers. services and employment, thanks to the use of highly specialized professional profiles. And the centers where clinical trials are carried out guarantee the growth of the researchers involved. Without forgetting – adds Corradini – the great advantages for patients who access to innovative therapies even a few years before reimbursement. To this must be added the savings for the NHS and for the individual structures, in terms of free supply of experimental and control drugs, the costs of which are entirely borne by the sponsoring companies ” .
It has been estimated, in the area of oncohematology alone, a potential saving of about 400 million euros every year – underlines Foce – and, therefore, can be estimated at a few billion for the whole system. From May 2014 the so-called ‘Lorenzin Law’ was issued which delegated the Government to reorganize and reform the legislation on clinical trials and which provided that, within 12 months from the date of its entry into force, one or more more delegated decrees for the full implementation of the European Regulation. This was not the case. This is why, once the delegation has expired, another delegation law may be needed again, to start over.
“The ‘Clinical Trial Information System’ becomes the single access point for the presentation, authorization and supervision of clinical trial applications in the European Union and in the countries of the European Economic Area (See). Currently – explains Fabrizio Pane, Treasurer Foce and Past President Italian Society of Hematology – sponsors must submit applications separately to the competent national authorities and ethics committees of each country to obtain regulatory approval. Thanks to Ctis, sponsors will be able to request authorization in a maximum of 30 SEE countries starting from a single application “.
“An identical regulatory framework in each Member State – underlines Pane – guarantees the conduct of clinical trials in a univocal way, with defined and certain timescales. Furthermore, it makes it easier and faster to enroll patients and close the studies. a delegated decree establishing the requirements of the centers authorized to conduct clinical trials, from phase I to IV, also providing for annual monitoring and the publication of the list of authorized structures in the portal of the Italian Medicines Agency “.
The European Regulation also requires that the persons in charge of validating and evaluating the application have no conflicts of interest, are independent from the sponsor, from the clinical trial site and from the investigators involved as well as from the financiers, and are exempt from any undue influence.
Rasi, ‘quickly recover lost ground’
“During the first year of validity of the Regulation, sponsors have the option of deciding whether to submit new trials following the previous standards or in accordance with the updated ones”, explains Guido Rasi, Past executive director of the European Medicines Agency ( Ema), full professor of Microbiology at the University of Tor Vergata in Rome and consultant to Commissioner Figliuolo for the Covid-19 emergency.
After January 31, 2023, all trials will have to be submitted under the new standards. And the studies still in progress will have to pass to the new criteria no later than January 31, 2025, but the competition has already started three weeks ago and we – underlines Rasi – are out of it. Other European states have in fact been ready for years, with the precise strategy of benefiting from the studies that the countries with an organizational delay will not be able to carry out. Italy is lagging behind and must quickly make up for lost ground, because research and innovation lead to improvements in the quality of assistance. To recover – explains Rasi – it will take years and investments. Having been ready now would have been at no cost. The entire ‘Country System’ risks remaining on the sidelines in terms of funding, international scope and collaboration with large centers “.
“Italy is at the top in the world for the results obtained in scientific research – remembers Walter Ricciardi, president of the ‘Mission Board for Cancer’ of the European Union and scientific advisor to the Minister of Health – we cannot lose this primacy. the following are known to be overcome: too many ethics committees, poor coordination between these bodies that often act on the basis of different protocols, excessively long authorization and start-up times for studies, enormous differences in the contracts for trials “.