In 8 years, our country has not yet aligned itself with the continental regulation from a regulatory point of view. important consequences for 35-40 thousand Italians who each year benefit from innovative treatments. We are already excluded from a quarter of the trials to be started
Italy risks losing the new train of clinical research that already started on January 31st, with the entry into force of the Clinical Trial Information System (CTIS), the single continental portal for trials. It 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, after 8 years from the resolution of the new legislation, has not yet adapted as required by the Regulation.
Problems to be solved quickly
the Federation of oncologists, cardiologists and hematologists (Foce) to launch the appeal: there are too many unresolved issues and heavy bureaucratic constraints. From the definition of the requirements of the authorized centers to the conduct of the trials, to the identification of ways to protect the independence of the studies and guarantee the absence of conflicts of interest. Up to the crucial point, namely the reduction of the territorial ethics committees to a maximum number of 40 (today there are about 90), in addition to the 3 of national significance. The delegated decrees, necessary to bridge the gap that separates Italy from other countries that have long since harmonized their system with the provisions of the European Regulation, should have been issued by January 31st. And it could take another year for a new immediate delegation law (because the previous one has expired) and the related delegated decrees. Now it is essential to make up for lost time, to avoid serious damage to both the health system and patients. In Italy, in fact, 35-40 thousand citizens are affected by various pathologies (two thirds represented by tumors, haematological and cardiovascular diseases) who every year, participating in clinical studies, can benefit from innovative treatments well in advance, even years, compared to to their availability and, therefore, of greater chances of recovery, also obtaining improvements in terms of quality of life.
Tumors, blood and cardiovascular diseases
Almost eight years have passed since the European Regulation was issued, but Italy risks remaining in a transition phase of one year and it will be impossible to join the rest of the Continent when the system is already consolidated – he says. Francesco Cognetti, president of Foce -. In this way we lose the advantages that derive 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. Based on the latest available data, in 2019, 672 experiments were authorized in Italy, 516 for profit and 156 for non-profit. And two-thirds are of interest to them altogether neoplasms, hematological and cardiovascular diseases, which among other things again produce two thirds of the annual mortality in our country. The Regulation marks an epochal change in clinical trials, moving from national management to coordination at the European level. If our country, as requested several times by the President of the Draghi Council, wants to regain international competitiveness, it must include scientific research as a top priority on the government agenda.
Savings for the National Health Service
Total public and private investments in this sector in Italy amount to over 750 million euros per year, of which 92% comes from funding from pharmaceutical companies for profit studies. Clinical research is an engine of economic and social development, which can offer an important contribution to the recovery of the current health crisis – he explains Paolo Corradini, vice president Foce and president of the Italian Society of Hematology -. There are also positive repercussions for service providers and on 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 the great advantages for patients, who access innovative therapies even a few years before reimbursement. To this must be added the savings for the National Health Service 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. In the area of oncohematology alone, a potential saving of about 400 million euros each year has been estimated and, therefore, can be estimated at a few billion for the whole system. Since May 2014 the so-called Lorenzin law (Law 11 January 2018, n.3) which delegated the Government for the reorganization and reform of the legislation on clinical trials and which provided that, within 12 months from the date of its entry into force, one or more decrees should be issued delegates for the full implementation of the European Regulation. So it was not. This is why, once the delegation has expired, another delegation law may be necessary again, and then start over again.
How the new European system works
The Clinical Trial Information System becomes the single access point for the submission, authorization and supervision of clinical trial applications in the European Union and in the countries of the European Economic Area (EEA) – underlines Fabrizio Pane, treasurer Foce -. Currently, sponsors must submit applications separately to the relevant national authorities and ethics committees of each country to obtain regulatory approval. Thanks to CTIS, sponsors will be able to apply for authorization in up to 30 EEA countries from a single application. An identical regulatory framework in each Member State guarantees the conduct of clinical trials in a unique way, with defined and certain timescales. It also makes it easier and faster to enroll patients and close the studies. Therefore, a delegated decree is needed that establishes 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. The reorganization of the ethics committees and their relocation outside the experimentation center must be envisaged – continues Pane -. This very important issue. To date, the ethics committees cannot evaluate a clinical study according to the criteria of the European Regulation, because they are not independent from the trial centers.
Ultimatum as of January 31, 2023
During the first year of validity of the Regulations, the sponsors have the option to decide whether to submit the new trials following the previous standards or in accordance with the updated ones – he explains Guido Rasi, Past Executive Director of the European Medicines Agency (Ema), Full Professor of Microbiology at the University of Tor Vergata in Rome -. After January 31, 2023, all trials will have to be submitted according to 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 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. It will take years and investments to recover. 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 at the top in the world for the results obtained in scientific research, we cannot lose this record – he highlights Walter Ricciardi, member of the Executive Council of the World Health Organization, president of the Mission Board for Cancer of the European Union and scientific advisor to the Minister of Health for the emergency Covid-19 -. The obstacles still to be overcome are known: 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.
Italy, research of excellence even with few resources
In Italy, multicentre and multinational trials are the most frequent, representing about 65% of the total – they explain Ciro Indolfi (vice president Foce and president of the Italian Society of Cardiology) e Francesco Romeo (Secretary Foce) -. For this reason, it is urgent to adapt to the requirements of the European Regulation, starting from the reorganization of the ethics committees, also reducing their number. Today there are about 90, far too many. expected to be reduced to forty and only 3 are those of national significance. This is a review of the entire clinical research system of which, to date, we see no trace. In Italy, expenditure on research and development amounts to 1.2% of GDP, while the average of European countries reaches 2%, with Germany almost 3%. Despite having few resources available, the studies conducted in Italy have changed clinical practice internationally in different types of tumors, leading to the modification of guidelines and recommendations – underlines Saverio Cinieri, president of the Italian Association of Medical Oncology -. And the Italian scientific works in the field of oncology are among the most cited in the world, immediately after those of the United Kingdom. In 2020, 377 thousand new cancer diagnoses were estimated in our country, survival 5 years after diagnosis reaches 65% in women and 59% in men: research and innovation are essential because they allow new therapies to be made available to patients effective much faster, improving the chances of healing. Italy cannot stop research due to bureaucratic obstacles.
February 22, 2022 (change February 22, 2022 | 20:02)
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