Skip to main content
SpringerLink
Log in

Uncertainty and the Ethics of Clinical Trials

  • Published:
Theoretical Medicine and Bioethics Aims and scope Submit manuscript

Abstract

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • R.J. Amdur C.J. Biddle (2001) ArticleTitleAn Algorithm for Evaluating the Ethics of Placebo-Controlled Trial International Journal of Cancer 96 261–269 Occurrence Handle10.1002/ijc.1026

    Article  Google Scholar 

  • R. Ashcroft (1999) ArticleTitleEquipoise Knowledge and Ethics in Clinical Research and Practice Bioethics 13 314–326 Occurrence Handle10.1111/1467-8519.00160

    Article  Google Scholar 

  • J.A. Chard R.J. Lilford (1998) ArticleTitleThe Use of Equipoise in Clinical Trials Social Science and Medicine 47 891–898 Occurrence Handle10.1016/S0277-9536(98)00153-1

    Article  Google Scholar 

  • B. Djulbegovic (2001) ArticleTitleAcknowledgement of Uncertainty: A Fundamental Means to Ensure Scientific and Ethical Validity in Clinical Research Current Oncology Reports 3 389–395

    Google Scholar 

  • Ellsberg, D. “Risk, Ambiguity, and the Savage Axioms” [1961] In Decision, Probability, and Utility. Edited by Peter Gärdenfors and Nils-Eric Sahlin. 245–269. Cambridge: Cambridge University Press, 1988

  • E.J. Emanuel F.G. Miller (2001) ArticleTitleThe Ethics of Placebo-Controlled Trials – A Middle Ground New England Journal of Medicine 345 915–919 Occurrence Handle10.1056/NEJM200109203451211

    Article  Google Scholar 

  • B. Freedman (1987) ArticleTitleEquipoise and the Ethics of Clinical Research New England Journal of Medicine 317 141–145 Occurrence Handle10.1056/NEJM198707163170304

    Article  Google Scholar 

  • C. Fried ( 1974) Medical Experimentation: Personal Integrity and Social Policy North Holland Amsterdam

    Google Scholar 

  • F. Gifford (1995) ArticleTitleCommunity-Equipoise and the Ethics of Randomized Clinical Trials Bioethics 9 127–148

    Google Scholar 

  • F. Gifford (2000) ArticleTitleFreedman’s ‘Clinical Equipoise’ and ‘Sliding-Scale All-Dimensions-Considered Equipose’ Journal of Medicine and Philosophy 25 399–426 Occurrence Handle10.1076/0360-5310(200008)25:4;1-A;FT399

    Article  Google Scholar 

  • S.O. Hansson (1993) Entscheidungsfindung bei Uneinigkeit der Experten Horst Zilleßen Peter C. Dienel Wendelin Strubelt (Eds) Die Modernisierung der Demokratie, Internationale Ansätze Westdeutscher Verlag Opladen 87–96

    Google Scholar 

  • S.O. Hansson (2004) ArticleTitleWeighing Risks and Benefits Topoi 23 145–152 Occurrence Handle10.1007/s11245-004-5371-z

    Article  Google Scholar 

  • J.T. Karlawish J. Lantos (1997) ArticleTitleCommunity Equipoise and the Architecture of Clinical Research Cambridge Quarterly of Healthcare Ethics 6 385–396 Occurrence Handle10.1017/S0963180100008136

    Article  Google Scholar 

  • I. Levi (1980) The Enterprise of Knowledge: An Essay on Knowledge, ␣Credal Probability, and Chance The MIT Press Cambridge MA

    Google Scholar 

  • I. Levi (, 1984) Decisions and Revisions: Philosophical Essays on Knowledge and Value Cambridge University Press Cambridge

    Google Scholar 

  • A. Lewis et al. (2002) ArticleTitlePlacebo-Controlled Trials and the Declaration of Helsinki Lancet 359 1337–1340 Occurrence Handle10.1016/S0140-6736(02)08277-6

    Article  Google Scholar 

  • R.J. Lilford (2003) ArticleTitleEthics of Clinical Trials from a Bayesian and Decision Analytic Perspective: Whose Equipoise Is it Anyway? BMJ 326 980–981 Occurrence Handle10.1136/bmj.326.7396.980

    Article  Google Scholar 

  • A.J. London (2001) ArticleTitleEquipoise and International Human-Subjects Research Bioethics 15 312–332 Occurrence Handle10.1111/1467-8519.00241

    Article  Google Scholar 

  • A.J. London J.B. Kadane (2003) ArticleTitleSham Surgery and Genuine Standards of Care: Can the Two Be Reconciled? American Journal of Bioethics 3 61–64 Occurrence Handle10.1162/152651603322614652

    Article  Google Scholar 

  • M. Longwood (1983) ArticleTitleSins of Omissions: The Non-Treatment of Controls in Clinical Trials, I Aristotelian Society, Supplementary Volume 57 207–222

    Google Scholar 

  • F.G. Miller D.L. Rosenstein. (2003) ArticleTitleThe Therapeutic Orientation to Clinical Trials New England Journal of Medicine 348 1383–1386 Occurrence Handle10.1056/NEJMsb030228

    Article  Google Scholar 

  • P.B. Miller C. Weijer. (2003) ArticleTitleRehabilitating Equipoise Kennedy Institute of Ethics Journal 13 93–118 Occurrence Handle10.1353/ken.2004.0008

    Article  Google Scholar 

  • P.B. Miller C. Weijer. (2003) ArticleTitleWill the Real Charles Fried Please Stand Up? Kennedy Institute of Ethics Journal 13 353–357 Occurrence Handle10.1353/ken.2004.0008

    Article  Google Scholar 

  • C.R. Palmer (2002) ArticleTitleEthics, Data-Dependent Designs, and the Strategy of Clinical Trials: Time to Start-Learning-As-We-Go? Statistical Methods in Medical Research 11 381–402 Occurrence Handle10.1191/0962280202sm298ra

    Article  Google Scholar 

  • R. Peto (1978) ArticleTitleClinical Trial Methodology Biomedicine 28 S24–S36

    Google Scholar 

  • D.L. Sackett (2000) ArticleTitleWhy Randomized Controlled Trials Fail But Needn’t: 1. Failure to Gain ‘Coal-Face’ Commitment and to Use the Uncertainty Principle CMAJ 162 1311–1314

    Google Scholar 

  • D.L. Sackett (2000) ArticleTitleEquipoise a Term Whose Time (If It Ever Came) Has Surely Gone CMAJ 163 835–836

    Google Scholar 

  • S.H. Shapiro et al. (2000) ArticleTitleWhy Sackett’s Analysis of Randomized Controlled Trials Fails, But Needn’t CMAJ 163 834–835

    Google Scholar 

  • R. Temple S.S. Ellenberg (2000) ArticleTitlePlacebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments Annals of Internal Medicine 133 455–463

    Google Scholar 

  • R.J. Temple R. Meyer. (2003) ArticleTitleContinued Need for Placebo in Many Cases Even When There is Effective Therapy Archives of Internal Medicine 163 371–373 Occurrence Handle10.1001/archinte.163.3.371-b

    Article  Google Scholar 

  • R.M. Veach (2002) ArticleTitleIndifference of Subjects: An Alternative to Equipoise in Randomized Clinical Trials Social Philosophy and Policy 19 295–323 Occurrence Handle10.1017/S0265052502192120

    Article  Google Scholar 

  • C. Weijer et al. (2000) ArticleTitleClinical Equipoise and Not the Uncertainty Principle is the Moral Underpinning of the Randomised Controlled Trial BMJ 321 756–757 Occurrence Handle10.1136/bmj.321.7263.756

    Article  Google Scholar 

  • C.W. Weijer K.C. Glass (2002) ArticleTitleThe Ethics of Placebo-Controlled Trials New England Journal of Medicine 346 382–383 Occurrence Handle10.1056/NEJM200201313460522

    Article  Google Scholar 

  • C. Weijer P.B. Miller (2004) ArticleTitleWhen Are Research Risks Reasonable in Relation to Anticipated Benefits? Nature Medicine 10 570–573 Occurrence Handle10.1038/nm0604-570

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Philosophy and the History of Technology, Royal Institute of Technology, Teknikringen 78, 100 44, Stockholm, Sweden

    Sven Ove Hansson

Authors
  1. Sven Ove Hansson
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sven Ove Hansson.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hansson, S.O. Uncertainty and the Ethics of Clinical Trials. Theor Med Bioeth 27, 149–167 (2006). https://doi.org/10.1007/s11017-006-0001-y

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11017-006-0001-y

Keywords

Search

Navigation