Changing how clinical trials are regulated

Posted on September 26, 2011 by


You might have spotted an interesting piece in the Telegraph today EU regulations hindering drug development, say charities. This is all about the EU directive governing clinical trials which is in the process of being revised. There are currently problems with how it’s working, with requirements resulting in unnecessary bureaucracy, inconsistencies in its application across the EU etc. which all together result in delays and escalating costs to get trials off the ground. Recognising this charities and associations funding health research across Europe have come together to make a joint statement outlining the problems we’d like to see tackled as the directive is revised.


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.

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.

In response to this, the EU is planning to revise the directive. They have recently consulted on how they should do this (read AMRC’s response here) and a proposal for the what the revised directive will look like is expected soon. This would then need to be debated by the european parliament.

The UK government committed in their plan for growth back in March this year to engage with this revision process in Europe to ensure the result improves the process of conducting clinical trials in the UK.

(more background and links here)

What does the statement say?

The statement gives a bit of background on clinical trials and the directive.

It includes a summary of the main negative impacts of the current directive

  • inconsistent interpretation across the EU – meaning requirements to get trials of the ground are different in different member states, a problem because trials can often take place in sites across several countries.
  • the requirements of the directive have considerably increased the administrative burden on staff
  • there is a one-size-fits-all approach which doesn’t work when testing very different drugs, some of which may be far better understood than others.

There are some case studies illustrating some of these difficulties at the end of the statement.

The statement then outlines what we’d like to see improved:

  • allow a more proportionate, risk-based approach to testing drugs – rather than the one-size-fits-all approach
  • greater clarity over the scope of the directive so it is less open to interpretation and will be more consistently applied across Europe
  • streamline the authorisation and assessment process to reduce the administrative burden to get a trial started
  • simplified approval and monitoring requirements
  • clearer, more detailed guidance

What next?

We’re waiting for the EU to respond to the recent consultation and publish a legislative proposal to revise the Directive. We’re expecting this in 2012. The revisions will then need to be scrutinised in detail by the European parliament before the changes can be adopted and rolled out across Europe.

Posted in: Policy, Research