A model clinical trials agreement
Authors: Michael D E Goodyear
Journal: BMJ (2006)

A model clinical trials agreementThe Department of Health's new model agreement raises questions about the NHS's relation with industry G ood 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. 1Anyone who has tried to carry out a clinical trial, particularly a multicentre one, knows only too well the frustrations of seemingly endless negotiations at the review process.While research may be a moral duty w1 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, without modification.The press release contained acclamation from leaders of industry and academia for what health minister Andy Burnham stated would "mean patients getting faster access to effective drugs and treatments," a laudable goal.The benefits of not having to renegotiate many of the elements within clinical trials agreements for every sponsor, study, and centre are clear.Before embracing this agreement with open arms, however, we should examine what it actually says and what the deeper implications might be.This agreement is not completely new, but a revision of a 2003 document, 4 and a concept that has now been examined in many jurisdictions. 5It applies only to contract research, defined as "commercial, industry sponsored trials of investigational medicinal products, involving NHS patients, undertaken in NHS hospitals, 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.The announcement has received little comment to date, although links have appeared on some NHS trust websites.This lack of interest is surprising as the agreement is the product of a unique consortium of industry, government, and academia-the UK Clinical Research Collaboration (www.ukcrc.org).In addition to industry, the collaboration lists an impressive collection of entities-referred to as partners-on its website, including government departments (Health, Trade and Industry), the NHS, the Medicines and Healthcare Products Regulatory Agency, the Academy of Medical Sciences, the Academy of Medical Royal Colleges, charities such as Cancer Research UK, the Medical Research Council, and the National Institute for Health and Clinical Excellence.The implication is that these bodies are equally committed to the agreement.Equally importantly, other organisations, such as the Central Office for Research Ethics Committees (www.corec.org.uk), are not mentioned.Research ethics committees are responsible for