The central issues in the debate surrounding the 2014 European Clinical Trials Regulation: protecting participants, and an international campaign for clinical data transparency

In July 2012, the European Commission presented a proposal for a new regulation on clinical trials. Its aim was to deregulate interventional research on human subjects in order to “make the European Union more attractive for clinical research”.

The new Clinical Trials Regulation, which repeals Directive 2001/20/EC, was adopted in early April 2014 after a single reading. It will apply from mid-2016.

Protecting participants and increasing transparency
Thanks to the mobilisation of many organisations seeking to place patients' interests ahead of those of the pharmaceutical industry, the European Parliament improved the European Commission's original proposals: the role of national ethics committees was restored, and greater transparency was required of companies with regard to the results of clinical trials.

EU member states' health ministers supported and reinforced the measures on clinical data transparency. They also reinstated certain measures to protect trial participants.

A missed opportunity to reorient clinical research
However, the Parliament and Council failed to seize this opportunity to demand that the evaluation of new drugs must include trials to compare them with reference  treatments (‘gold-standard'), yet such a measure is needed in order to reorient research towards patients' real needs.

Safeguarding the advances obtained in terms of transparency
The new Clinical Trials Regulation should provide greater transparency with regard to clinical trial results and data.

However, a proposed directive on trade secrets published by the European Commission in November 2013 and the free trade agreement currently being negotiated between the United States and the European Union (TTIP) could jeopardise these gains in transparency.

©Prescrire November 2014