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The ethics of randomised controlled trials: A matter of statistical belief?

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  • Analysing Ethics
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Abstract

This paper outlines the approaches of two apparently competing schools of statistics. The criticisms made by supporters of Bayesian statistics about conventional Frequentist statistics are explained, and the Bayesian claim that their method enables research into new treatments without the need for clinical trials is examined in detail. Several further important issues are considered, including: the use of historical controls and data routinely collected on patients; balance in randomised trials; the possibility of giving information to patients; patient choice and patient autonomy; and how widely the results of clinical trials can be used. It is concluded that good statistical techniques in the design and analysis of medical studies are essential, but the statistical school used in developing such techniques is relatively unimportant.

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References

  1. Urbach, P. (1993). The value of randomisation and control in clinical trials. In,Statistics in Medicine—Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27–28 June 1991, Volume 12, ed. by D. Ashby, John Wiley and Sons, Chichester.

    Google Scholar 

  2. Campbell, M.J. and Machin, D. (1993).Medical Statistics: A Commonsense Approach, second edition, John Wiley and Sons, Chichester.

    Google Scholar 

  3. Berry, D.A. (1993). The case for Bayesianism in clinical trials. In,Statistics in Medicine—Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27–28 June 1991, Volume 12, ed. by D. Ashby, John Wiley and Sons, Chichester.

    Google Scholar 

  4. Carr, R., Hutton, J.L., Jenkins, J., Lucas, J.A. and Amphlett, N.W. (1990). Transfusion of ABO mismatched platelets leads to early platelet refractoriness.British Journal of Haematology 75, 408–413.

    PubMed  Google Scholar 

  5. Evans, S.J.W. (1993). Invited contribution to discussion of Urbach. In,Statistics in Medicine—Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27–28 June 1991, Volume 12, ed. by D. Ashby, John Wiley and Sons, Chichester.

    Google Scholar 

  6. Dorling, J. (1993). Discussion of: the value of randomization and control in clinical trials. In,Statistics in Medicine—Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27–28 June 1991, Volume 12, ed. by D. Ashby, John Wiley and Sons, Chichester.

    Google Scholar 

  7. Byar, D.P. (1980). Why data bases should not replace randomized trials.Biometrics 36, 337–342.

    PubMed  Google Scholar 

  8. Hutton, J.L. and Owens, R.G. (1993). Bayesian sample size calculations and prior beliefs about child sexual abuse.The Statistician 42, 399–404.

    Google Scholar 

  9. Antman, E.M., Lau, J., Kupelnick, B., Mosteller, F. and Chalmers, T.C. (1992). A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts.Journal of the American Medical Association 268, 240–248.

    Article  PubMed  Google Scholar 

  10. Hutton, J.L. (1995). The critical role of statistics in professional ethics.Journal of Applied Philosophy 12(5), 253–261.

    Google Scholar 

  11. Chalmers, I. (1991). Improving the quality and dissemination of reviews of clinical research. In,The Future of Medical Journals: In Commemoration of 150 Years of the British Medical Journal, ed. by S. Lock, British Medical Journal, London.

    Google Scholar 

  12. Lewis, B.V. (1993). Diagnostic dilatation and curettage in young women.British Medical Journal 306, 225–226.

    PubMed  Google Scholar 

  13. Howson, C. (1993). Discussion of: the case for Frequentism in clinicals trails. In,Statistics in Medicine—Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27–28 June 1991, Volume 12, ed. by D. Ashby, John Wiley and Sons, Chichester.

    Google Scholar 

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Hutton, J.L. The ethics of randomised controlled trials: A matter of statistical belief?. Health Care Anal 4, 95–102 (1996). https://doi.org/10.1007/BF02251209

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