The Department of Health's new clinical trials agreement raises questions about the NHS's relation with the drug industry, says an editorial published on bmj.com today.
Following the tragedy of the TGN1412 trial, the Department of Health announced last month that a model clinical trials agreement has been finalised. This provides a template that can be used by all NHS trusts for any clinical trial, without modification.
But before embracing this agreement with open arms, we should examine what it actually says and what the deeper implications might be, warns Professor Michael Goodyear of Dalhousie University, Canada.
The agreement is the product of a unique consortium of industry, government, and academia, but other organisations, such as the Central Office for Research Ethics Committees, are not mentioned, despite being central to many issues covered in the agreement.
The agreement also applies only to contract research (commercial, industry sponsored trials usually directed towards pharmaceutical product licensing). It does not apply to phase I testing with healthy volunteers (as in TGN1412), to studies initiated by investigators, to trials in which the sponsor merely provides funding, or to research in non-NHS institutions.
While collaboration is admirable, we must realise that the development of a business model for research is a primary motivation behind this initiative, says Goodyear. As the guidance document states, the NHS is being "harnessed" in what is essentially a competitive model.
A surprising and disturbing element of the agreement relates to the crucial principles of transparency and accountability in research. Rather than incorporating and upholding the new and widely supported standards for an open research culture, the agreement has embedded an older and more problematic industry standard.
And, given that this agreement appears at a time when public trust in the drug industry has never been lower, the likelihood of guilt by association is appreciable, he warns.
The removal of counterproductive roadblocks in research regulations is generally a good thing, but research is far more than just a business, he writes. No matter how important the research is, thoughtful analysis cannot be bypassed for the sake of convenience.
The government and academia would be well advised to maintain a respectable distance from sources of funding, he concludes. The NHS is not for sale.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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