Clinical research, Italy is back in the game of European trials

Four decrees signed by Minister Orazio Schillaci on January 30 will allow Italy to keep pace with the rest of Europe in terms of clinical trials. An event eagerly awaited by the scientific community, institutions, companies and obviously by patients. In fact, every year 750 million euros are invested in trials in Italy and there are about 40 thousand citizens involved in clinical trials, who can benefit from innovative treatments well in advance of their availability and, therefore, with greater chances of recovery. “A virtuous system that risked remaining at a standstill due to delays in adapting to European Regulation 536 of 2014, which harmonized the evaluation and authorization process of a clinical study conducted in several Member States. Now, however, with the decrees that have just been signed, Italy has finally complied with the Community legislation”, explained Francesco Cognetti, President of FOCE (Federation of Oncologists, Cardiologists and Hematologists). “I am convinced that clinical research is an Italian excellence and that in this way, thanks to the effort we have made together with Regions and administrations, it can be increasingly valued, thanks to less bureaucracy without renouncing scientific rigour”, declared the Minister Schillaci. “Knowing the quality of Italian researchers, I am convinced that their contribution can now be increasingly relevant at a Community level”.

In 2019, 672 trials were authorized in our country, 516 profit and 156 non-profit; two thirds of which dedicated to neoplasms, haematological and cardiovascular diseases. Failure to comply with the European Regulation has led to a drop in the number of studies involving our country: from January to October 2022, 428 applications to start studies (clinical trial applications) were submitted, of which only 87 involved the Italy compared to 142 in France, 132 in Spain and 116 in Germany. “In the absence of regulatory compliance, a real halving has been estimated, that is, around 300 studies would have been lost compared to 672 in 2019, with serious consequences for patients and the ‘country system’. Minister Schillaci’s decrees have averted very serious damage to the approximately 40,000 Italian patients who find a benefit from early treatment with innovative drugs and strategies, as well as bringing advantage in the training of top-level professionals,” Cognetti underlined.

Reduction of ethics committees

One of the cornerstones of compliance with European legislation is that which concerns the number of ethics committees, the bodies which at the local level must approve the trials. “The decrees establish the reduction of the territorial ethics committees from 90 to 40, in addition to the 3 of national value, also thanks to the virtuous synergy developed between the Ministry, AIFA and the Regions. All this translates into acceleration of decisions and less bureaucratic constraints. The Minister’s decree which regulates the transitional phase relating to the evaluation activities and the methods of interaction between the coordination centre, the territorial ethics committees, those of national value and AIFA is also fundamental”, explained Giorgio Palù, President of AIFA ( Italian Medicines Agency).

A training opportunity

Participation in clinical trials allows doctors to train in the use of new therapies so that they can make the best use of them once they are available. “For 8 years, our country has not implemented the legislative fulfilments necessary to adapt and allow centers to register and participate in clinical trials organized with the new model – underlined Paolo Corradini, President of SIE (Italian Society of Hematology) -. From today the scenario changes. The savings represented by the costs and benefits for the National Health Service for experimental drugs and the services entirely borne by the sponsor companies must also be considered. A potential saving of approximately 400 million euros each year has been estimated, in the area of ​​oncohematology alone, and therefore estimated at a few billion for the entire system. Not only. The positive effect on employment must also be considered, with the use of highly specialized personnel and, therefore, the related industries and the positive economic effects for service providers, with an added value of 2-2.5 euros per every euro invested in clinical trials”.

The community platform

The ‘Clinical Trial Information System’, the single continental portal, 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). “Until now, sponsors had to submit applications separately to the national competent authorities and ethics committees of each country to obtain regulatory approval – explained Guido Rasi, Past Executive Director of the European Medicines Agency (EMA) and Professor Professor of Microbiology at the University of Tor Vergata in Rome -. 2022 was the first year of validity of the Regulation, in which sponsors exercised the option to decide whether to submit new trials following the previous standards or in accordance with the updated ones. From today all trials must be submitted according to the new standards. Italy risked losing the new train of clinical research. Now we can once again attract investments in this sector, continuing to collaborate with large international centers. Italian scientific works are among the most cited in the world”.

Research is priority

“From the point of view of administrative simplification, the determination of the single tariff for clinical studies, which has been awaited for a long time, is also fundamental – says Saverio Cinieri, President of AIOM (Italian Association of Medical Oncology) -. After these important decisions, we hope that scientific research will become a priority on the government agenda. We also ask for more resources. Despite having few available, the studies conducted in Italy have changed clinical practice internationally in different types of tumors, leading to the modification of guidelines and recommendations. We are facing a real cancer epidemic. In 2022, 390,700 new diagnoses were estimated in Italy. In two years, the increase was 14,100 cases. Research and prevention must be the cornerstones of the commitment of clinicians and institutions against cancer”.

An overhaul of the entire system

“We are facing a revision of the entire research system in Italy – concluded Pasquale Perrone Filardi, President of SIC (Italian Society of Cardiology) -. On the one hand, the reduction of the territorial ethics committees, on the other, the identification of ways to protect the independence of the studies and guarantee the absence of conflicts of interest. Indeed, the European Regulation requires that the persons in charge of validating and evaluating the application have no conflicts of interest, are independent of the promoter, the clinical trial site and the investigators involved as well as the lenders, and are free from any undue influence. In this sense, one of the ministerial decrees harmonises the legislation governing, in particular, the functions of the Ethics Committees and their composition, also in order to guarantee their independence”.