What do we want to see in the new Clinical Trials Regulation?

Posted on November 23, 2012 by


In July 2012, following much criticism of the laws governing clinical trials across the EU, the EU Commission published plans to revise the legislation. These plans will be put in place through a new Clinical Trials Regulation. But first, the Regulation will be debated by MEPs and the Council of the European Union (which is made up of ministers from each EU state) who can make amendments to the text. They  must come to agreement before it can become law.

To feed into these debates and ensure that the final Regulation addresses some of the current problems with the law and helps us conduct clinical trials safely and efficiently, Cancer Research UK have worked with organisations across the EU involved in medical research to make a joint statement on the Regulation – Proposal for an EU Regulation on Clinical Trials – A joint statement from non-commercial and commercial organisations. This statement outlines what is good in the proposed Regulation and what could be improved to better support medical research. This has been sent to MEPs to help inform their discussions about the Regulation.


Clinical trials are an essential step in turning a discovery in a lab into a treatment for patients. New drugs must go through a series of controlled tests to ensure they are safe and effective. Clinical trials, involving healthy volunteers or patients, help us establish whether a drug is safe and how well it works. This POSTnote gives a great overview of clinical trials.

Clinical trials across the EU are governed by the Clinical Trials Directive which was made in 2001.

However, there have been difficulties in implementing the regulations and concerns that they may actually be leading to unnecessary delays and escalating costs. The European Commission quotes a decrease of 25% of clinical trials conducted in the EU during the period between 2007 and 2011.

In response to this, the EU is revising the Directive. They consulted widely before publishing their proposals in a new Clinical Trials Regulation in July this year. (more background on the discussions so far here)

What are the key things we want to see in the new Clinical Trials Regulation?

We welcome lots of the proposals in the new Regulation including:

  • the improved clarification of the scope of clinical research covered by the Regulation – there have been difficulties because the scope of the current Directive has been interpreted differently across the EU.
  • proposals to make regulation more proportionate to the level of risk associated with a trial by introducing a new category of low-risk interventions
  • creating a single portal for submitting all documents
  • introducing tight timelines for regulators to provide an opinion.

But there are some areas we think could be improved including:

  • clarification of the scope has improved, but this could be tightened up further.
  • the two-tier risk approach treats ‘medium risk’ studies (ie where a drug is being tested outside its normal license) in the same way as entirely new chemicals.
  • while a single application portal is a great idea, it is also a large IT project and will need careful management if it is to deliver.

Check out the joint statement for lots more detail on where we think the Regulation can still be improved.

What next?

The Regulation is beginning its round of debates within the European Parliament and Council. Glenis Willmott, a UK Labour MEP, is acting as the rapporteur who will steer the discussion of the Clinical Trials Regulation through the European Parliament. You can follow the process here. The Commission expects these discussions to be completed, and the new regulation to come into effect, in 2016.

This week Earl Howe gave evidence to the Lords EU Sub-committee on several areas of EU health policy and their impact on the UK healthcare sector including the proposed new Clinical Trials Regulation. You can listen to the discussion here.

AMRC will be working with the other organisations supporting this statement to feed into the debate.

Posted in: Policy