Academics raise alarm over trial costs
pharmafile | December 15, 2004 | News story | |
Leading UK academic researchers say extra costs and bureaucracy from new European laws are killing off their work, and have appealed for more pharmaceutical industry funding.
Introduced in May, the Clinical Trials Directive was intended to encourage research by standardising procedures across the EU and establish compliance with Good Clinical Practice.
Less than one year on, the university-based researchers are struggling to deal with the new burden of extra cost and regulatory authorisation the Directive has brought with it.
Kate Law, head of clinical trials at Cancer Research UK, said: "We have five academic units around the UK and all have had problems initiating trials. I have never seen so much despondency. The legal people are having a field day as they are stopping trials getting started."
Cancer Research UK says it receives some educational grants from pharmaceutical companies but points out that there are many areas of research, on rare illnesses and paediatrics for instance, for which industry funding is very difficult to find.
Professor Clive Adams, head of adult psychiatry at Leeds University, said: "The Clinical Trials Directive is a catastrophe and puts further bureaucratic barriers up. It is hard enough to get money without these extra regulations. The Directive is likely to scare folk off from doing such research.
"Some of our work, the evaluative work, is already funded by the pharmaceutical industry but a possible solution to this increased European bureaucracy is disinterested funding from pharmaceutical companies."
Professor Steve Bloom, head of investigative research at Imperial College London, believes the Directive fixed something that wasn't broken.
He said: "The Directive is tantamount to killing people as a lot of discoveries are no longer being made."
He said funding trials was often "beyond our financial capability", adding: "We will have to go to big pharma, but if the drug won't make money, they won't do it."
Professor Bloom uses pharma seed funding for research and says his recent trials on a modified version of an appetite-suppressing hormone would not have been possible under the new regulations.
He agreed that disinterested pharmaceutical funding could be the long-term solution to preserving research in British universities but suggested it could constrain the scope of academic studies, particularly when return on investment becomes a major factor.
But Richard Ley, spokesman for the ABPI, believes the idea of disinterested funding from pharma is impractical in a competitive market.
He said: "The idea of disinterested funding is all very well but pharmaceutical companies are not charities."
He stressed that the industry maintained close contact with academia, and that funding was usually linked to promising drug candidates in early stages of development.
"But it is unlikely that pharma companies will give money for academics to do clinical trials. They simply couldn't afford it," he concluded:
Industry-university collaborations are the sort of joined-up thinking the government wants to see more of in the UK, having recently launched a five-year industrial policy aimed at making Britain the most attractive place in the world for scientific research.
