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Jul 15, 2009 Researchers demand more harmonization of European rules for approving clinical studies (from Nature)..
Daniel Cressey
Europe must streamline its system for approving clinical trials that take place in different countries, researchers and pharmaceutical-industry representatives told a meeting in Brussels on 7 July.
Despite efforts to harmonize the way European countries approve clinical trials, a researcher may see their proposed study rejected in one nation but approved in another. The number of these 'divergent decisions' is small, but they are just one of the reasons why researchers are calling for a single clinical-trial authorization (CTA) process for multinational trials.
Many blame the European Union (EU) law governing such studies, the Clinical Trials Directive, for the current problems. Written into the national laws of most member states in 2004, scientists believe that the directive has led to needless extra paperwork before research is approved — especially for the 60% or so of trials that need to negotiate differing approval systems in different countries.
"The implementation [of the directive] has resulted in a fragmented and complex regulatory environment," Angelika Joos, from the Belgian subsidiary of pharmaceutical company Merck Sharp and Dohme, told the meeting. "The current system has added a lot of administrative cost but we have not added a lot of benefit for public health."
“It's true the system is clearly not very good, but it's important to remember how it was before.”
Stefan Führing
European Commission
Jane Apperley, chair of the department of haematology at Imperial College London, says that in her field "the perception is [that] the introduction of the directive has had a negative impact".
Alan Tyndall of the University of Basel in Switzerland warned that the situation is worst for scientists who work on rare disorders with only a few patients in each country and so must run trials in many countries. It is "almost impossible for these people to do their work", Tyndall said.
Difficulties may take the form of countries asking for changes to trial documents or differences in the hoops researchers must jump through before beginning their work. At their most extreme, they may lead to those divergent decisions. In 2007 there were 45 of these in the EU.
Choosing the changes
"It's true the system is clearly not very good, but it's important to remember how it was before," says Stefan Führing of the pharmaceuticals unit of the EC (European Commission). "We are aware that some of the guidelines … give too much leeway to member states to bring in additional requirements. Differences [between] member states should not be permissible."
Führing points out that that the EC is already consulting interested parties about proposed revisions of the guidelines that are issued to European member states on requirements for clinical-trial researchers.
The Brussels meeting itself was the first in a series that will deliver recommendations to a review of the directive planned for 2010.
There is already a Voluntary Harmonization Procedure, in which national authorities will comment on certain trial proposals before they are submitted, in an attempt to ease some difficulties. Some who were at the meeting think that, in the words of Martyn Ward of Britain's Medicines and Healthcare products Regulatory Agency, "we could achieve a lot with the current legislation without radical change".
But the European Federation of Pharmaceutical Industries and Associations (EFPIA) is pushing for a new regulation that would run alongside the current system and specifically deal with multinational trials. "We think it would offer more efficient use of European research and get attention beyond Europe and be attractive internationally," said Mats Ericson, regulatory policy director at international pharmaceutical company Amgen, who was speaking on behalf of EFPIA.« Back |
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