EMA recommends global trials framework

The European Medicines Agency (EMA) has discussed the possibility of a global framework for clinical trials at an international workshop, given the fact that the majority of clinical trials for medicines approved in Europe are conducted outside of the EMA’s regulatory reach.

“Wherever in the world we stand, the majority of clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in different cultural settings. However, we all rely on the same trials to make decisions,” Fergus Sweeney, Head of Inspections at the EMA, explained in astatement.

According to the EMA, only 38.8% of patients enrolled in pivotal clinical trials between 2005 and 2009 received their treatments in the EU and the EEA. These trials involved more than 44000 clinical trial sites in 89 countries, with the data being used to support almost 350 EMA marketing authorizations.

The workshop was held to discuss views on the EMA’s draft reflection paper on “ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA”. The reflection paper sets out a number of recommendations, and considers that EU regulators should only expect/require studies in support of an EU marketing authorization application that would also be ethically acceptable in the EU. “There should not be a different standard applied to trials conducted in the EU compared to those conducted elsewhere,” said the statement.

The workshop highlighted three main needs in order to meet the reality of safe, global clinical trials:

• cooperation and networking between regulatory authorities and ethics committees involved in supervising clinical trials
• greater transparency of clinical trials, including patient registers and the provision of information about ethical and good clinical practice aspects
• involve patients early on in trial design to ensure adequate protection.

“What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator’s sites are located and patients recruited. The Agency is committed to build and extend its relationship with regulators in all parts of the world and with international organisations to work to standards agreed and recognised by all,” said Thomas Lönngren, Executive Director of the EMA.

Consultation on the reflection paper is open until 30 September 2010. Comments should be sent to ctrefpaper@ema.europa.eu.

www.ema.europa.eu