A European consumer perspective on clinical trial reporting

26th November 2013

This is a guest post by Ilaria Passarani, Senior Health Policy Officer at BEUC – The European Consumers’ Organisation, which is a supporter of the AllTrials campaign.

The volunteers who take part in clinical trials put their own lives at risk of unexpected adverse drug reactions. They do so in the spirit of altruism to contribute to scientific progress for the benefit of society – therefore the results of such trials belong to them and to society at large. Clinical trial data cannot be considered trade secrets as they are generated ‘using’ human beings. Many drug scandals caused could have been avoided (and public money saved) had clinical trials of some unsafe and ineffective medicines be publicly available for secondary analysis.

Moreover, making clinical trial data available can facilitate the work of health technology assessment bodies that require complete information on clinical trial results in order to make sound cost-effectiveness analyses on which price and reimbursement decisions will be made.

Some argue that the publication of clinical trial data would undermine trust in the regulatory approval system governing pharmaceuticals, due to risks of misinterpretation and misuse of information. On the contrary, we believe that granting access to the data on which decisions are made is a necessary tool to restore trust in the work of medicines regulators and ultimately in the safety of the medicines on the market. Moreover, so far there is no evidence of potential misuse of data that generated unsubstantiated health scares, while there is evidence of the risks of the lack of public disclosure of important information.

Finally, openness and transparency contribute to strengthening the principles of democracy and respect for fundamental rights as laid down in the Treaty and in the Charter of Fundamental Rights of the European Union. Pharmaceutical companies will sooner or later have to pull down the fences around clinical trial data and accept that regulators will open their data vaults to researchers and patients.

The BEUC is currently supporting the European Medicine’s Agency in a case in the European court, where two pharmaceutical companies, AbbVie and Intermune, are suing the agency to prevent release of clinical trial data. The results of this case are due in the next couple of weeks and may be crucial to clinical trial transparency in Europe.