BMJ  2006;333:1083-1084 (25 November), doi:10.1136/bmj.39030.418229.BE (published 17 November 2006)

Editorials

A model clinical trials agreement

The Department of Health's new model agreement raises questions about the NHS's relation with industry

The first 150 words of the full text of this article appear below.

Good clinical research is hard to do at the best of times, and there is a growing perception that the regulatory environment is making it increasingly difficult to plan and carry out clinical trials within a realistic time frame. A recent editorial in the BMJ claimed that the 2004 European Union clinical trials directive has hindered this process.1 Anyone who has tried to carry out a clinical trial, particularly a multicentre one, knows only too well the frustrations of seemingly endless negotiations during the review process. While research may be a moral dutyw1 in our search for better ways of caring, we must always be on guard against using patients and volunteers as a means to an end, as the TGN1412 tragedy recently emphasised.2

On 30 October 2006, the Department of Health announced that a model clinical trials agreement had been finalised—a remarkable achievement that should be welcomed by all . . . [Full text of this article]

Michael D E Goodyear, assistant professor

1 Division of Medical Oncology, Department of Medicine, Dalhousie University, Halifax, NS, Canada B3H 2Y9

MGoodyear@dal.ca


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