“On clinical research, after 13 years, Italy has finally adapted to the European Regulation 536 of 2014, thanks to the 4 decrees signed by the Minister of Health on 30 January 2023 which introduce some important principles in Italian clinical trials: standardization uniformity, simplification administration, time certainty, quality assurance and the need for the participation of aware patients”. So Saverio Cinieri, president of the Italian Oncological Medicine Association (Aiom), in an interview published by ‘Alleati per la Salute’ (www.alleatiperlasalute.it), the portal dedicated to medical-scientific information created by Novartis.
Specifically – the article reports – with the decree of the Minister of Health of 26 January 2023, with agreement in the State-Regions Conference, the territorial ethics committees were reduced to 40 (there were 90) which have the task of evaluating clinical trials on medical devices and medicines for human use, also thanks to the virtuous synergy developed between the ministry, the Italian Medicines Agency (Aifa), the Regions and autonomous Provinces. Furthermore, with the decree of the Minister of Health of 27 January 2023, the transitional phase was regulated in relation to the evaluation activities and the methods of interaction between the Coordination Centre, the territorial ethics committees, those of national value and AIFA. Another decree harmonises the legislation governing, in particular, the functions of the Ethics Committees, the criteria for the division of responsibilities, for their composition, to ensure that the members are in possession of documented knowledge and experience in clinical trials of medicines and medical devices, also in order to guarantee their independence. The other awaited provision, and decisive in administrative simplification, is the decree determining the single tariff for clinical trials.
“This signature is essential for continuing to carry out clinical research in Italy”, underlines the president of Aiom who, quoting the data from the latest Altems report, recalls: “672 clinical studies were carried out in 2019 alone and 40% were on oncology The majority were for profit, from drug companies, but 23.2% were basic clinical research studies”, non-profit studies that directly meet “the requests of patient associations and the clinician. The majority of these studies were phase 3, standard therapy versus standard therapy and innovative drug”.
750 million euros are invested each year in clinical trials in Italy – the article details – and around 40 thousand citizens are involved in clinical trials, who can benefit from innovative treatments well in advance of their availability and, therefore, from greater possibilities of healing. From today, all trials must be submitted according to the new standards established by the decree, which harmonized the evaluation and authorization process of a clinical study conducted in several Member States.
“Now – Cinieri reiterates – we can give our patients the most innovative molecules”. After all, “participating in clinical research is always an advantage for a patient” because “the criteria with which it is followed” are precise, such as “checks and exams with fixed deadlines” and periodic questionnaires with “questions to understand if the drug works and, above all”, to verify “the quality of life of the patient. It has now become imperative to understand how much clinical research also gives an advantage in terms of quality of life and not just in terms of survival”.
From January to October 2022 – the article concludes – 428 applications to start studies (clinical trial applications) were submitted, of which only 87 involved 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, i.e. about 300 studies would have been lost compared to 672 in 2019, with serious consequences for patients and the ‘country system’. The complete article is available at: https://www.alleatiperlasalute.it/alla-scoperta-di/nuovi-decreti-sulle-sperimentazioni-cliniche-cosa-cambia.