Italian regulator under fire for inaction over missing clinical trial results

The former head of the Italian medicines agency AIFA has called for transparency conditions to be placed on future public medical funding in the country.

His call comes in response to a report published yesterday by TranspariMED and allied groups showing that at least 1,299 clinical trials involving Italian patients had not made their results public as required by European guidelines.

Worst institutions are concentrated in Italy

An report published last week found that 9 out of the 15 major European research institutions with the worst trial reporting record are located in Italy.

"Even one unreported trial creates damage"

Luca Li Bassi, who used to head the Italian regulator, told newspaper La Verita that:

“Even one unreported trial is enough to create damage: maybe that trial investigated a subgroup of people who do not respond to a certain drug, and we do not know."

“There can be interventions that do not require a change in the legislative framework, but which could have an immediate effect.”

“Every year, AIFA manages several million euros dedicated to pharmaceutical research. Transparency could be one of the criteria necessary for access to funds." "

We probably won't be able to recover all of that that we have lost, but it would be a signal of change.”

Other regulators do far better

The newspaper contrasted AIFA’s failures with the successful approaches taken by regulators elsewhere in Europe.

"We make sure that trial sponsors are aware of the rules and constantly monitor the level of reporting,” the Danish Medicines Agency told the newspaper. “We [have now] ensured the publication of the results of at least 76% of the trials that had not correctly reported data since 2017.”

The newspaper also noted that “the Dutch regulator [CCMO] has hired dedicated staff to follow up with non-compliant sponsors.”

Waste of Italian public money

According to La Verita, AIFA’s 2022 budget includes more than 10 million euros for scientific research, including 2 million euros to support independent research programs.

Previous research has shown that the Italian Ministry of Health also hands out money for medical research without placing any transparency conditions on its grantees, the only major funder in Europe to do so.

Note: La Verita ran a two-page story on this issue on 03 October 2022. It is accessible to subscribers only. TranspariMED can share a PDF copy upon request.