The European Union Regulation 536/2014 on clinical trials on medicinal products for human use (so called Clinical Trials Regulation – CTR) was approved by the Council of the European Union and published on the Official Journal of the EU in April 2014. This new regulation replaces 2001 Directive on Clinical Trials. It regulates the way clinical trials are designed and performed in Europe.

Unfortunately, the old Directive imposed very complex bureaucratic and legal limits to the organisation of clinical trials. The effect was that international trials (organised across more than 1 country) in the EU dropped dramatically by 25%. This was particularly detrimental for low incidence cancers (like rare cancers) for which it is difficult to find enough patients in one single country.

The new Regulation shall facilitate the set-up of international clinical trials, which is fundamental for the development of new, effective treatments against cancers, particularly those considerate as rare.

The current regulation entered into force in May 2016.

Q&A on the CTR

General information on clinical trials from the European Commission

EU Clinical Trials Register

Also on Clinical trials by ECPC: Clinical Trials Database