Abstract
In this paper, I consider the impact of research regulation on the duty of doctors to help to resolve uncertainties about the effects of treatments; in particular, treatments already in use within ‘normal’ or ‘usual’ clinical practice. After providing examples of ways in which current research regulation is obstructing this professional duty, I consider the influence of “a confused ethical analysis”, the double-standard in informed consent to treatment within and outside of controlled trials, and the failure of research regulators to use their powers to reduce unnecessary research and promote full publication of necessary research. I suggest that these problems should be addressed by more thoughtful ethical analyses, more effective protection of the interests of patients by research regulators and empirical research to inform the future development of research regulation. Because ethicists and research regulators have paid insufficient attention to these issues, I conclude that they have contributed to the avoidable suffering and deaths of millions of people, the vast majority of whom have not been participants in clinical research.
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Acknowledgements
I am grateful to Frank Wells and the European Forum for Good Clinical Practice for the invitation to give the 2007 Joseph Hoet Lecture, and to Richard Ashcroft, Frank Davidoff, Hugh Davies, Mary Dixon-Woods, Benjamin Djulbegovic, Imogen Evans, Paul Glasziou, Martin Goller, David Healy, Elina Hemminki, Edmund Hey, Tony Hope, Margaret McCartney, Howard Mann, Andy Oxman, Ching Ling Pang, Michael Parker, Sophie Petit-Zeman, Helen Roberts, Ian Roberts, David Sackett, John Saunders, Hazel Thornton, Andrew Trehearne, Charles Warlow, Frank Wells, Peter Wrobel and two anonymous commentators for helpful comments on an earlier draft of this paper. Readers should not assume that any of these people endorse the current version of this paper.
I declare that I have no conflicts of interest, other than a wish for more relevant and valid evaluation of the effects of the treatments I and other patients may be offered. No sources of funding were used to assist in the preparation of this paper; however, I am grateful to the Medical Research Council and Department of Health for my salary.
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1 This paper is based on issues addressed in the Joseph Hoet Memorial Lecture, delivered at a meeting of the European Forum for Good Clinical Practice, Brussels, Belgium on 30 January 2007; an account of the Joseph Hoet Lecture, as delivered, has been published in the Newsletter of the European Forum for Good Clinical Practice, Spring/Summer 2007, pages 3–5.
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Chalmers, I. Regulation of Therapeutic Research is Compromising the Interests of Patients. Int J Pharm Med 21, 395–404 (2007). https://doi.org/10.2165/00124363-200721060-00004
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DOI: https://doi.org/10.2165/00124363-200721060-00004