EU publishes proposal to improve regulation of clinical trials

Posted on July 18, 2012 by


The European Commission has published a new Regulation to update the EU Clincial Trials Directive. The current directive has been criticised as disproportionate, complex and delaying trials getting off the ground. The proposed new regulation will now be debated by the European Parliament and Council. When they reach agreement, it will be adopted across Europe. The plan is for this to happen by 2016. As a regulation, once adopted it will take force directly across all EU member states, rather than being transposed into each states’ law. This means the rules governing clinical trials will be the same across Europe, but also means the discussion in Europe is our one chance to get this right and ensure the regulation works for patients and researchers.


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 planning to revise the directive. They have recently consulted on how they should do this (read AMRC’s response here).

AMRC also supported a joint statement outlining how the directive needs to be revised to enable clinical trials to go ahead while putting in the necessary safeguards to protect patients and researchers. In particular we called for:

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

And if you want lots of detail, check out Cancer Research UK’s recommendations to reform the Clinical Trials Directive, Supporting Research, Protecting patients – really clear with lots of case studies illustrating the issues.

The UK government committed in their plan for growth back in March 2011 to engage with this revision process in Europe to ensure the result improves the process of conducting clinical trials in the UK.

What happened today?

After all the consultation, the proposed new Regulation was published. Check out the press release and Q&A and, what I really like, the citizen’s summary which simplifies down and explains the basic purpose of the Regulation clearly.

In particular the citizen’s summary outlines how the new Regulation aims to tackle some of the concerns we have raised with the Directive:

  • greater collaboration on approval – authorities in EU countries would work together and be held to the same timeframe when approving clinical trials, ensuring they are thoroughly and expertly assessed.
  • rules for clinical trials based on the actual risk posed to the safety of participants.
  • greater openness in clinical trials both within and outside the EU, including more public access to the results, whether positive or negative.
  • The rules for clinical trials would continue to protect patients’ rights and safety and ensure data is reliable.

This Regulation will now be debated by the European Parliament and Council until they reach a shared position through the co-decision process (also know as ordinary legislative procedure – more information and a flowchart explaining it here). The plan is for this to be complete and the new regulation to come into effect in 2016.

There’s a nice Nature news piece with more background, Europe proposes revision of clinical trial rules

What are AMRC doing?

We welcomed the publication of the Regulation today – the regulation surrounding clinical trials needs to be revised urgently to help us streamline the process of conducting research in the UK. Currently there are lots of duplications and delays but if we can get the regulation right, ensuring patient safety and making it easier to get clinical trials off the ground, the UK will be a very attractive location to base research. This will make it easier for medical research charities to fund more trials of new treatments and provide more opportunities for patients who would like to trial new treatments – something patients tell us they want to do.

Sharmila Nebhrajani, AMRC’s chief executive said:

The current Clinical Trials Directive creates major barriers to getting trials of new treatments off the ground and urgently needs revising.

The proposed new Regulation published today is a real opportunity to streamline regulation, making the UK an attractive location for health research. 72% of people we polled told us they want the chance to be involved in clinical trials but this is hampered by a regulatory regime that is still too complex and unwieldy.

As a regulation that will take effect directly across Europe, it is vital the UK government engages with Europe now to get this right, and we look forward to working with them for the benefit of patients and researchers.

We are now going to take a detailed look at the proposals in the regulation and work together with funders of medical research across Europe to engage with the legislative process to help get this right.

Posted in: Policy