Investigating regulatory failures in medical research to improve patient safety and healthcare across Europe

France | Norway

Description

Clinical trials investigate whether medicines are safe and effective for use. Their results have significant public health, public spending and commercial implications. In the past, unpublished trial results have led to many avoidable patient deaths and the waste of billions of Euros of taxpayers’ money.
Since 2022, across Europe, pharma companies and universities have been legally required to make public the results of clinical trials of medicines. An academic study has shown that out of the first 234 clinical trials subject to the new law, less than half had results available. In the coming years, thousands more clinical trials will be completed. Their results will only be consistently and reliably made public if national regulators take corrective action now.
We aim to determine what the 30 European national medicines agencies are doing to ensure that the law is followed and patient safety is safeguarded. We aim to raise awareness of these issues which can look technical from afar but are in fact extremely human, as people who volunteer to enter trials and patients more generally can be personally and directly affected by gaps in the medical evidence base.

“Patients across Europe and the world suffer from the consequences of undisclosed medical data. We will check whether national regulators across 30 countries are taking action to ensure compliance with EU transparency rules.” — Till Bruckner, Postdoctoral Research Fellow

 

Project Team

Media outlet

Blast!

Paris, France
https://www.blast-info.fr

Ariane Denoyel

Investigative journalist
France

Blast!

Blast!

Ariane Denoyel

Ariane Denoyel

Research organisation

UiT The Arctic University of Norway

Tromsø, Norway
https://en.uit.no/startsida

Till Bruckner

Postdoctoral Research Fellow
Norway

UiT The Arctic University of Norway

UiT The Arctic University of Norway

Till Bruckner

Till Bruckner