What’s the latest EU consultation on clinical trials about?

Posted on February 11, 2011 by


The European Commission are asking for our views on their plans to revise the clinical trials directive.  They are hoping to publish legislation to revise the directive in 2012. This is the second in a series of consultations they have held on this; this time they are asking for our comments on quite detailed proposals. Revising the directive is one of the recommendations the Academy of Medical Sciences made to improve regulation in the UK. We’ve got until May to feed back to them.


Clinical trials are a key part of the process of developing new medicines and treatments; they are how we test potential medicines on people.

Medical research charities fund lots of clinical trials. In 2009-10 over 3000 clinical studies were conducted in the NHS; 37% were funded by AMRC member charities.

Back in 2001, the clinical trials directive (PDF) – aka Directive 2001/20/EC – was made to bring all clinical trials conducted within the EU under the same regulations. It aimed to ensure:

  • The protection of the health and safety of people taking part in clinical trials
  • The ethical soundness of the clinical trial
  • The reliability and robustness of the data generated in clinical trials
  • Streamlining the process of conducting clinical trials, i.e. simplification and harmonisation of all the administrative provisions that govern them to try and make doing them more cost-efficient.

But since its introduction there have been difficulties in implementing the regulations and concerns that they may actually be leading to unnecessary delays and escalating costs. There are some examples of some of the delays faced in conducting clinical trials here. And:

a recent analysis from Cancer Research UK showed that after its funding for a study has been agreed, it now takes an average of 621 days to recruit the first patient.

Aware of this, in January 2010 the European Commission held a public consultation investigating the impacts of the European Clinical Trials Directive – ‘Assessment of the functioning of the Clinical Trials Directive 2001/20/EC‘. AMRC responded to this consultation and you can read a summary of all the responses to it here.

What has happened now?

The Commission has published another consultation, Revision of the ‘Clinical Trials Directive’ 2001/20/EC: Concept paper submitted for public consultation. This builds on the previous consultation but is very clear that it is not trying to repeat that. Instead it aims to lay out some more concrete ideas for how the directive should be revised and asks for views on these. As a result it gets right into the detail and technical issues that revisions to the directive might throw up.

As part of the revisions, there will also need to be a detailed impact assessment exercise. The Directorate leading the revision has some numbers but want to ensure they are correct, so part of this consultation asks for additional quantifiable information about clinical trials that might be valuable.  The data they have at the moment is all in the annex; it includes some interesting facts on the number of clinical trials in the EU.

In the EU/EEA, approximately 400-6000 clinical trials are performed each year.

Approximately 64% of clinical trials are sponsored by the pharmaceutical industry and 36% by other actors, such as academics.

What next?

We have until 13 May 2011 to respond to this new consultation; something medical research charities will be looking at carefully as clinical trials are a key step in ensuring the discoveries we fund are reaching the people who need them. And streamlining the process of funding clinical trials in the UK won’t just benefit charities, it will also be valuable to encourage investors to choose to fund research in the UK; something that fits nicely with the governments growth review (see my post here).

The Academy of Medical Sciences’ recent review of regulation (see my brief summary of this report here) looked at the delays experienced in conducting clinical trials and one of their recommendations was that:

The Government, supported by the MHRA, should seek to influence the European Commission to act quickly to revise the EU Clinical Trials Directive. The Directive should be amended to:

a. Reduce the scope of the Directive through the revision of the definitions set out in article 2.

b. Ensure that approval and monitoring requirements are proportionate to risk.

c. Simplify the requirements for the reporting of adverse events.

The European Commission is planning to put forward a legislative proposal to revise the Directive in 2012.

Posted in: Policy