Trish Groves on European clinical trials

Trish Groves The calls to cut the red tape that ties up clinical trials in Europe grow louder and louder (see Editor’s choice, It’s time to change how Europe regulates research). Now Europe’s legislators are listening hard, and the red tape is beginning to fray.

The medical research regulators (aka “national competent authorities”) in the EU’s 27 member states are going to pilot next year a much simpler application process. To get drug trials approved triallists will need to complete just one online application that all the regulators will share.

And, to back up those calls, there’s now some systematic evidence on the problems triallists face. The Impact on Clinical Research of European Legislation survey (ICREL), conducted this summer, asked competent authorities, commercial and academic trial sponsors, and research ethics committees across Europe to compare their experiences of trial approval in 2003 (before the clinical trials directive kicked in) and in 2007. Released in Brussels on 2 December, ICREL’s early results are clear. Everyone doing multicentre international trials wants a much simpler approval process that will work across all member states; they want approval-lite for trials that pose few risks to patients; and – perhaps surprisingly – even industry would like the trials directive to be replaced by a firmer EU regulation that would make all member states do the same thing and would stamp out cumbersome national variations and related delays. The survey was extensive and pretty robust and had good response rates from all but the ethics committees, many of whom were simply too busy to take part.

Dr Ingrid Klingmann, ICREL’s coordinator, explained that, when the EU Clinical Trials Directive was being written, the different interest groups took their own corners. This time they’re speaking with one voice, and ICREL has given them a mouthpiece. Stefan Fuhring of the European Commission – despite one call from the audience to promise on the spot that the directive would be changed – couldn’t say much in summing up, but he seemed suitably pleased that ICREL had provided a baseline against which any changes in legislation might be judged. Roll on ICREL 2, replied the audience.

That voice is also being heard in other European forums. Over the past year the European Science Foundation (ESF) and European Medical Research Councils (EMRC) have built the case for lessening the regulation of the investigator-driven (ie academic) trials that ask research questions that really matter to patients. ESF’s Forward Look report, produced through five separate workshops and a consensus conference and covering everything from study design to data sharing, will be published by Spring 2009. It will include a detailed, evidence based call for much lighter regulation (and thus fewer delays and lower costs) for low risk trials. Low risk means, for instance, a head to head pragmatic trial of two current treatments in a real life group of hospital patients.

EMRC has a wider strategy on Strengthening Medical Research in Europe, but acknowledges that revision of the clinical trials directive is one of the most important strategic tools to enable Europe’s academics and industries to build research capacity, compete better with the US and Asia, and make Europe a healthier place.

European Commission elections in late 2009 mean that there won’t be any decision on revising the directive till at least 2010. So there’s still a long way to go. But at least the campaign to make trials easier is building momentum and gathering data along the way. Back in 2007, at the meeting in London where the ICREL survey was conceived, Professor Rory Collins of the University of Oxford argued that the entire EU approach was misconceived, with an obsessive attention to procedural detail obscuring the real purpose of clinical trials. The regulators’ single application and – in the UK – the integrated research application system (IRAS) for NHS studies should soon begin to make that purpose clear again.

Competing interests: Trish Groves was a member of the ESF Forward Look group on data sharing and spoke at the consensus conference in Strasbourg (travel costs paid by ESF), and spoke at the launch meeting of the EMRC white paper on strengthening medical research in Europe (costs paid by EMRC). The BMJ paid for Trish to attend the Brussels launch of the ICREL results.

Trish Groves, deputy editor BMJ, 11 December 2008