A model clinical trials agreement

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.39030.418229.BE (Published 23 November 2006) Cite this as: BMJ 2006;333:1083
  1. Michael D E Goodyear, assistant professor (MGoodyear@dal.ca)
  1. 1Division of Medical Oncology, Department of Medicine, Dalhousie University, Halifax, NS, Canada B3H 2Y9

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

    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 stakeholders in clinical research in the United Kingdom.3 This provides a template that can be used by all National Health Service trusts for any clinical trial, …

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