Italian regulator AIFA urged to take action over 577 missing clinical trial results
Twenty-two major Italian institutions have made public the results of only 5 out of their 1,155 clinical trials, a new analysis by TranspariMED shows.
Luca Li Bassi, former Director General of the Italian Medicines Agency (AIFA), said:
“Sharing clinical trial results is not only a formal requirement of current regulations. It’s a scientific and moral imperative, for both better and faster scientific innovation, as well as for the benefit of patients, who can access new and more effective treatments earlier.”
In total, an estimated 577 drug trials run by major Italian sponsors are missing results. Three institutions alone account for an estimated 200 missing results: Agostino Gemelli (76 results missing), AOU Bologna (63), and Ospedale San Raffaele (61).
Mario Negri uploaded most of its missing trial results last year, and now boasts a respectable reporting rate of over 88%. Only two of its verifiably due trials are still missing results.
Ospedale San Raffaele will begin uploading its missing results soon. Marco Bregni, director of its clinical trials unit, told newspaper La Verita that a review of the hospital's drug trials is already in progress.
In contrast, Agostino Gemelli did not respond to La Verita’s enquiry about its transparency plans.
It is unclear whether AOU Bologna and other major sponsors have already started to fix the problem.
European Union rules adopted in 2014 require companies, universities and hospitals running drug trials to make their results public on a dedicated public registry within just a year of study completion – far more rapidly than the 2-3 year timeline typical for academic journals.
Till Bruckner, founder of TranspariMED, said:
"Why should Italian patients with cancer and other life-threatening diseases have to wait longer than patients in other European countries until clinical trial results are made public? This is unethical and a waste of public money.”
Rita Banzi, head of the Health Regulatory Policy Center of the Mario Negri Institute, said:
“Knowing the key results of a clinical trial upon completion of analyses allows researchers to share any findings without having to wait for scientific journals.”
Clinical trial transparency levels in Italy are far below those in other major European countries.
Out of the 27 largest trial sponsors in Italy, only two – pharma companies Chiesi and Italfarmaco – are fully compliant with European Union disclosure rules. A further three institutions have a mixed disclosure record. Most of the remaining 22 sponsors have not uploaded a single trial result yet.
Seven Italian institutions running Covid-19 trials are in currently in violation of transparency rules, raising concerns that the results of these trials may never be made public at all, especially if those trials are terminated early.
According to the World Health Organisation, around half of all clinical trials never make their results public at all, generating an estimated $85 billion in medical research waste every year.
From late 2021, when the EU Clinical Trial Regulation fully comes into force, national law in all EU member states – including Italy – will mandate the disclosure of trial results on the registry, giving regulators a solid legal basis for imposing fines on institutions that violate the law.
Data on the registry strongly suggests that the Italian Medicines Agency AIFA has so far largely neglected the issue, in stark contrast to more proactive regulators in other European countries, at least one of which has already announced sanctions. It is currently unclear whether and how AIFA is planning to enforce the law.
Italian MEP Piernicola Pedicini, who recently wrote to AIFA to encourage it to take action, told newspaper La Verita that:
“AIFA should contact the most important Italian promoters and support them to achieve better standards. Research that remains invisible contributes neither to scientific progress nor to the improvement of clinical practice. This lack of transparency could lead to less careful choices in care and therefore potential harm to patients."
Till Bruckner, founder of TranspariMED, said:
"It is completely unacceptable that AIFA silently stands by while Italian medical research institutions break rules designed to protect patients. AIFA should present the public with a clear plan for enforcing the law. In parallel, the Italian government should cut off future research funding for institutions that violate the law."
Reporting rates in Italy are currently far lower than in other European countries, including Austria, Denmark, Germany, Ireland, and the UK.
Click below to download TranspariMED's full report.
A snaphot of newspaper La Verita's coverage is below.
TranspariMED will continue to track Italian institutions’ reporting performance and AIFA’s actions through regular progress reports. Italian trial sponsors are encouraged to review TranspariMED’s collection of transparency tools.