Europe’s leading academic research bodies are today (26 September) appealing to Members of the European Parliament (MEPs) to push for a streamlining of the approval process for clinical trials, saying the current rules are holding back medical progress. Revision needs to focus on getting rid of bureaucracy, they say in a statement.
“It’s vital the recommendations put forward in this statement are taken forward,” says Liselotte Højgaard, chair of the European Medical Research Councils. “The current system of regulation for clinical trials is unnecessarily complex and bureaucratic.”
Complaints about the Clinical Trial Directive 2001 have been stacking up for some time, leading the Commission to announce plans for reform in December 2008. DG Sanco published its preliminary view of what changes are needed in a concept paper in February 2011, and the subsequent public consultation closed in May.
Based on this, officials at the EU’s health directorate DG Sanco are currently in the thick of drafting the reforms, but the research organisations want to begin educating and informing MEPs about the shortcomings of the existing rules and how they should be revised before the Commission publishes its formal proposals and parliamentary debate begins.
That is expected to happen around mid-2012. For now, the medical research bodies are attempting to show how urgent this matter is, highlighting ways in which the current regulations are holding up research into new treatments without increasing safety for patients taking part in clinical trials.
Betty McBride, head of policy at the UK research charity, the British Heart Foundation said, “The Commission and Parliament need to seize this opportunity to reform the directive and ensure clinical trials are conducted safely and to high standards without overwhelming researchers with red tape.”
The problems with the Clinical Trials Directive 2001 are well-rehearsed. Although it was intended to harmonise the conduct of clinical trials across Europe, the opposite has happened, with different member states interpreting the rules differently. This is not only generating unnecessary bureaucracy and increasing costs, it can also result in the morally dubious situation of patients in the same trial in different countries having differing levels of safeguarding and insurance.
The cost and time taken to set up clinical studies has made it harder for academic trials to be staged. It is estimated that there has been a 65 per cent increase in the time it takes researchers to get approval for studies and a 75 per cent increase in administrative costs, since the Directive came into force in 2004. In some cases, a trial has been approved in one member state and not in another.
The centrepiece of the Commission’s concept paper is a plan to set up a single EU portal for the submission of an application to carry out a multinational trial. The research organisations say in their statement that they are in favour of this in principle because it could reduce the administrative burden of needing to make multiple submissions to different national authorities at the time of the initial application, and when seeking amendments and reporting trial data.
But the research organisations believe there needs to be a full impact assessment to ensure the single portal does not lead to increased costs or longer approval times, saying, “Until there is more detail as to how this would operate in practice, it is difficult to be strongly supportive of the proposal.”
In addition, the concept paper has not identified how safety reporting will be simplified to get rid of the current, unnecessary duplication, which has been identified as a major problem of the current system.There is also a need for additional clarification on other issues, such as what constitutes a substantial amendment to a study protocol, the research organisations say.
The overall objective must be proportionate regulation that protects patients and supports globally competitive research, believes John Bell, President of the UK’s Academy of Medical Sciences. “We must make changes to clarify the scope of the current European Directive and stop a one size fits all approach to trial regulation,” he said.
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