Health Minister Orazio Schillaci signs implementing decrees: Italy enters a new system for clinical trials

Each year, forty thousand patients can be offered innovative treatment by participating in clinical trials, far in advance of future universal supply. Two out of three of these patients have cancer, blood or cardiovascular diseases.

Nine years ago, the European Union introduced new regulations for these trials only to be adopted by Italy on 30th January – just four days ago –thanks to Health Minister Orazio Schillaci, who signed the missing implementation decrees.
Without this signature, patients and researchers could have been left off the European track.

After all the unheeded warnings of the past few years, this news was welcomed with great enthusiasm by Francesco Cognetti, a luminary in the world of Oncology and president of the Federation of Oncologists, Cardiologists and Haematologists (Foce): “We want to thank Minister Schillaci for upholding the appeal of clinicians. The scientific community welcomes the full implementation of the European Regulations into our system, which will allow Italian researchers to maintain their leading role in the world. In 2019, Italy authorised 672 clinical trials, of which 516 were profit and 156 non-profit. Two-thirds of these trials involved neoplasms, blood and cardiovascular diseases, which account for two-thirds of the annual mortality rate”.

The Clinical Trial Information System (CTIS), the single European portal for trials, was established by European Regulations no. 536 of 2014 and imposed common rules to optimise the assessment and authorisation process of clinical trials conducted in member states.

Thanks to the implementation of this decree, the CTIS has become the only access point for the submission, authorisation and supervision of clinical trial applications within the European Union. This will avoid an enormous waste of time and energy as well as major bureaucratic delays.