Improving Medical Treatment Requires a Risk-based Approach to the Regulation of Clinical Trials

Current EU legislation represents a major hurdle to improving medical treatment due to the straight-jacket of EU legislation that the 2001 Clinical Trials Directive imposes, a group of leading European medical scientists charged today in a position paper issued in Brussels and Strasbourg.

(ag/ehj) – The paper issued by the European Science Foundation (ESF) and its European Medical Research Councils (EMRC) welcomes the planned revision of the 2001 Clinical Trials Directive expected later this year, but urges the Commission to take the opportunity to introduce a series of improvements to the Directive. These improvements include streamlining procedures, introducing a risk-based approach to authorising clinical trials and crucially ensuring greater harmonisation in the implementation of EU rules at national level so that clinical trials can take place across national borders.“Balancing these aims with the imperative of maintaining a high level of patient safety is the major challenge facing the revision,” said Professor Liselotte Højgaard, Chair of the EMRC.

Finding that balance, however, is the key to preserving Europe’s position as an innovative and competitive research area.The 2001 Directive was a landmark in the pursuit of quality medicine in Europe. It aimed to facilitate clinical research across the EU, while at the same time maintaining a high level of protection for public health. It established specific provisions regarding the conduct of clinical trials on humans involving medicinal products in particular relating to the implementation of good clinical practice defined as a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials.

The position paper “Proposal for a revision of the ‘Clinical Trials Directive (2001/20/EC) and other recommendations to facilitate clinical trials” is available on the ESF website:

It is widely recognised that the 2001 Directive radically enhanced the quality of Europe’s clinical trials on which patient safety resides, and the ESF, EMRC and many other European organisations want the revision to preserve that high standard. But in line with Europe’s 2020 objectives it must also be designed to boost innovation and improve medical treatments.

Since its implementation in 2003 the Directive has been under a lot of criticism for adding to rather than reducing red tape. No one argues the benefits of the strict regulations for high risk trials involving experimental medicines for humans, but the EMRC argues in favour of a sliding scale of requirements depending precisely on the risk involved. In this way low-risk trials or comparative trials could benefit from a less restrictive framework than high risk trials. Clinical researchers wanting to verify the effectiveness of one already licensed medication over another – aspirin versus paracetamol for example – would not have to fulfil the full gamut of rules. “It is time now to align requirements with the risk involved,” stressed Prof Højgaard.

Another key objective for research is to harmonise national implementation of the clinical trials directive. Currently the 27 member states have each translated the Directive into national law with different definitions and varying restrictions so every pan-European trial has to deal with that complexity. This is a non-starter for academic research groups with a low research budget. The EMRC therefore welcomes indications from the Commission that improved harmonisation and cooperation in clinical trials will be part of the revised legislative.

“Excellence in clinical research requires a truly functioning harmonisation,” emphasised Professor Højgaard. “We urge the Commission, European Parliament and the member states to enact a law that unifies clinical trials in Europe.“
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