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Clinical research, benefits for 40 thousand Italian patients a year

2023-02-02T09:30:43.301Z


Clinical research, benefits for 40,000 Italian patients a yearEvery year 40,000 Italian patients benefit from clinical trials and 750 million euros are invested in trials: now, thanks to our country's alignment with the new European regulation on clinical trials, Italy will be able stay... (ANSA)


Every year 40,000 Italian patients benefit from clinical trials and 750 million euros are invested in trials: now, thanks to our country's alignment with the new European regulation on clinical trials, Italy will be able to remain "at the top" in this sector.

This was underlined by the Federation of Cardiologists, Oncologists and Hematologists (Foce) in a meeting organized to put the spotlight on the new legislation.

Four decrees of the Minister of Health Orazio Schillaci in fact adapt our system.

For the president of Foce, Francesco Cognetti, it is an "epochal change: due to the delays - he says - we risked a halving of the trials. Two thirds concern tumors, hematological and cardiovascular diseases".

Every year, therefore, around 40,000 citizens are involved in clinical trials, who can benefit from innovative treatments well in advance of their availability and, therefore, with greater chances of recovery.

From today all trials must be submitted according to the new standards established by the European Regulation 536 of 2014, which harmonized the evaluation and authorization process of a clinical study conducted in several Member States.

And Italy, after long delays, has finally adapted to EU legislation, thanks to the four decrees signed by the Minister of Health on 30 January 2023. The territorial ethics committees have been reduced to 40, guaranteeing the independence of the studies and the absence of conflicts of interest.

"We thank Minister Schillaci for having accepted the appeal of the clinicians - says Cognetti -, this will allow Italian research to remain at the top in the world". 

In 2019, in our country, says Cognetti, "672 trials were authorized, 516 profit and 156 non-profit. And two thirds overall concern neoplasms, haematological and cardiovascular diseases, which among other things produce two thirds of the annual mortality. In recent months, we have repeatedly urged the institutions, pointing out the risks of failure to comply with the European Regulation. The first signs were truly worrying. From January to October 2022, 428 applications to start studies were presented, of which only 87 involved Italy compared to 142 from France, 132 from Spain and 116 from Germany".

In the absence of regulatory compliance, he notes, "a real halving has been estimated, i.e. about 300 studies would have been lost compared to 672 in 2019,


Source: ansa

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