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In Global Health Research, Is It Legitimate To Stop Clinical Trials Early on Account of Their Opportunity Costs?

  • James V. Lavery mail,

    jim.lavery@utoronto.ca (JVL); buchanan@schoolph.umass.edu (DB)

    Affiliations: Centre for Research on Inner City Health and Centre for Global Health Research, The Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada, Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada, McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Toronto, Ontario, Canada

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  • Peter A. Singer,

    Affiliation: McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Toronto, Ontario, Canada

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  • Renee Ridzon,

    Affiliation: HIV, TB & Reproductive Health Program, Bill & Melinda Gates Foundation, Seattle, Washington, United States of America

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  • Jerome A. Singh,

    Affiliations: Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada, McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Toronto, Ontario, Canada, Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, KwaZulu-Natal, South Africa

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  • Arthur S. Slutsky,

    Affiliations: Departments of Medicine and Critical Care, and The Keenan Research Centre in the Li Ka Shing Knowledge2 Institute of St. Michael's Hospital, Toronto, Ontario, Canada, Departments of Medicine, Surgery and Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada

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  • Joseph J. Anisko,

    Affiliation: Independent Consultant, West Chester, Pennsylvania, United States of America

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  • David Buchanan mail

    jim.lavery@utoronto.ca (JVL); buchanan@schoolph.umass.edu (DB)

    Affiliation: School of Public Health and Health Sciences, University of Massachusetts, Amherst, Massachusetts, United States of America

    X
  • Published: June 09, 2009
  • DOI: 10.1371/journal.pmed.1000071

Reader Comments (1)

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Baffling the principle of equipoise

Posted by Paul_Vaucher on 11 Jun 2009 at 08:30 GMT

Lavery et al have proposed a new concept for stopping trials related to "opportunity costs". This procedure is meant to distribute resources "wisely" to trials for which "we" hope more promising results. The problem with this proposal is it makes phase III clinical trials senseless. If we can truly consider that it is possible to put up a procedure to judge an intervention as more promising one than another, why bother wasting resources on expensive, time consuming trials to show the same thing?

With this proposal, Lavery et al have hit the cornerstone of clinical trials: the principle of equipoise. Assuming we do not know if an intervention is beneficial is not only ethically indispensable, but it is the basis of hypothesis testing.

Opportunity costs is nevertheless an important issue on how to wisely distribute resources. Peer reviewing protocols by experts before starting trials could help accord funds for trials with up to date innovations. We should also take the time to develop interventions before testing them. Secrecy related to concurrence between developers and financial expectations from marketing are limitations to both these procedures. The “opportunity cost” stopping rule could be focusing on the wrong target to limit research costs.

No competing interests declared.