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With the publication of more than 70 pages of legalese, the European Union (EU) has completed the tortuous overhaul of regulations governing its clinical trials.
The appearance in the document in the Official Journal of the European Union marks the end of years of lobbying from scientists, research funders and industry groups. Observers hope that the new legislation will make it easier for researchers to conduct clinical trials in the EU, and arrest a marked decline — of 25% over four years, by some counts — in such work in the bloc’s 28 member states.
The old system — the Clinical Trials Directive — was often criticized as having excessive red tape. The European Commission estimates that all the changes could save researchers €800 million a year.
"The old Clinical Trials Directive was a catastrophe," says Michael Rawlins, one of the UK's leading doctors and chair of the working group behind a UK Academy of Medical Sciences report on clinical trials in the UK, which strongly criticised the old directive.
"This is clearly an improvement. I still have reservations about aspects of it. Much of it will be in the implementation."
Key among the changes is a centralized system for the approval of clinical trials — so that researchers running trials in more than one country can apply just once for approval. Another change, much requested by researchers, is that certain trials deemed to be ‘low risk’ will be subjected to lighter regulation.
Another key aim of the regulation is to increase transparency. It requires the publication of results, including negative ones — a key demand of groups such as AllTrials, which have campaigned for more openness in medical research.
“Harmonizing the rules and introducing the single portal for applications is a huge step forward, which will make cross-border trials much easier to carry out,” says Glenis Willmott, a member of the European Parliament who was the rapporteur on the regulation. “This is especially vital for research into rare diseases, such as childhood cancers.”
Medical researchers in the EU have for years demanded change to the system. Thus, in July 2012, the European Commission outlined a new package of clinical-trials legislation, which has since been following a complicated path between the three branches of EU power: the commission, the parliament and the council. Agreement was reached on a compromise text earlier this year and the legislation was published on 27 May — and will go into force no earlier than mid-2016.
The regulation has been welcomed in some quarters. The London-based European Medicines Agency, which will have a key role in running information technology to support the new system, said that it would “open up a new era for the conduct of clinical trials in the EU, ensuring that Europe remains an attractive centre for clinical research”.
Markus Hartmann, an independent consultant in medical regulatory affairs based in Trier, Germany says that there is “no question” that the new regulation is an improvement over the old directive. However, he laments that the final plan is not as radical as the original proposal from the commission.
“The commission went two steps ahead. And as a typically European process, the discussions … resulted in an outcome which is only one step forward,” he says.
Among the potential problems in the final agreement, says Hartmann, is the stipulation that master files from trials be kept for 25 years, out of step with internationally accepted practice of 15 years. There are also some decisions that are left up to member states, creating the potential for future problems if countries adopt incompatible rules.
Also missing from the final version of the regulation — to the disappointment of some experts — is a mooted national indemnity programme, in which low-risk trials would have been insured by each member state. This could have saved individual researchers from having to obtain their own insurance, which can be expensive. And the deadline for decisions on applications to conduct clinical trials is 60 days — longer than originally proposed.
It now remains to be seen whether the new legislation will help to reverse the decline in number of applications to conduct clinical trials in the EU.
“I think it will stop the decline, but I’m sceptical if we will see an increase to gain back [what was lost],” says Hartmann.
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