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Monday, 29 October, 2001, 00:04 GMT
Red-tape 'disaster' for medical research
test tube
Researchers are worried about the impact of the directive
The future of clinical trials in the UK will be jeopardised by a new EU directive, according to research experts.

Although the directive will not come into force in the UK for two years, charities which fund research here are already worried about its consequences.

They say it will radically increase how much it costs to carry out academic work, or many drug trials.

This could divert such trials away from the UK, sparking a new "brain drain" of talent to US research institutions.

Ultimately, they say, patients will suffer because they will have fewer opportunities to take part in trials of the latest drugs.

The idea behind the directive is to tighten up ethics and safety in trials across the EU.

Dossier required

However, it will require a huge dossier of information to be compiled by researcher about virtually every aspect of the trial.

Every piece of data produced will also have to be verified by an independent monitoring team.

Dr Richard Sullivan, head of clinical programmes at the Cancer Research Campaign, said that sufficient monitoring is already in place to make sure trials were conducted properly.

He told BBC News Online: "The vastly increased requirement for reporting of adverse events will significantly raise the cost of carrying out such research in the UK.

"We have already got inbuilt safety-checks in trials."

He said that another aim of the directive - to make research fraud more difficult - will fail because determined cheats would still succeed.

"There's no evidence that doing this would help the situation," he said.

This will be a disaster for patients

Dr Richard Sullivan, Cancer Research Campaign
The Cancer Research Campaign, he said, would probably stop funding the type of trials most likely to be affected by the directive - "phase III" trials in which large numbers of patients are recruited to test the performance of a particular drug or treatment.

Dr Sullivan said that the directive would also sound the "death knell" for the efforts of the government's new "clinical research network", which aims to recruit thousands more patients onto this kind of trial.

"This will be a disaster for patients," he said.

There will simply be too much paperwork, and trials will be too expensive

Professor Michael Stevens, University of Bristol
Other leading clinicians are expressing their fears about the directive.

Professor Michael Stephens, an expert in paediatric oncology at the University of Bristol, said the directive could "severely hamper" clinical research.

"I am certainly worried that this, when implicated, could seriously affect the way that phase III trials can be carried out in this country.

"There will simply be too much paperwork, and trials will be too expensive."

See also:

15 Oct 01 | Health
Research fraud faces clampdown
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