P.Mean >> Category >> Equipoise in research (created 2007-06-19).

In a study where you randomly assign patients to two or more different treatments, you need to provide assurance that none of the patients is being harmed by having a chance at receiving an inferior therapy. This assurance has several different definitions coming from several different research perspectives, but a commonly used term is "equipoise". These pages discuss some of the ethical and practical issues associated with equipoise as well as debate over the proper interpretation of this and other closely related terms. Articles are arranged by date with the most recent entries at the top. Also see Category: Ethics in research. You can find outside resources at the bottom of this page.


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Other resources:

  1. Eurich D, Tsuyuki R, Majumdar S, et al. Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality. Trials. 2009;10(1):12. Available at: http://www.trialsjournal.com/content/10/1/12 [Accessed March 9, 2009].
  2. Adil E. Shamoo. The Myth of Equipoise in Phase 1 Clinical Trials. The Medscape Journal of Medicine > Bioethics. 2008;10(11):254. Abstract: "Phase 1 clinical research trials using healthy volunteers are conducted for the sole purpose of serving the public good (a utilitarian concept). The literature on equipoise analysis does not exclude phase 1 trials with controls or healthy volunteers from the claim of being in "equipoise." The continued perpetuation of this ethically and scientifically invalid concept undermines the ethics of research with human subjects." [Accessed July 17, 2010]. Available at: http://www.medscape.com/viewarticle/582554.
  3. Amy Harmon. New Drugs Stir Debate on Rules of Clinical Trials. The New York Times. 2010. Excerpt: "Controlled trials have for decades been considered essential for proving a drug’s value before it can go to market. But the continuing trial of the melanoma drug, PLX4032, has ignited an anguished debate among oncologists about whether a controlled trial that measures a drug’s impact on extending life is still the best method for evaluating hundreds of genetically targeted cancer drugs being developed." [Accessed September 20, 2010]. Available at: http://www.nytimes.com/2010/09/19/health/research/19trial.html.

Creative Commons License All of the material above this paragraph is licensed under a Creative Commons Attribution 3.0 United States License. This page was written by Steve Simon and was last modified on 2010-09-20. The material below this paragraph links to my old website, StATS. Although I wrote all of the material listed below, my ex-employer, Children's Mercy Hospital, has claimed copyright ownership of this material. The brief excerpts shown here are included under the fair use provisions of U.S. Copyright laws.


5. Stats: Two articles debating equipoise (September 9, 2005). A frequent contributor to the IRBForum (HM) mentioned a couple of articles that discuss equipoise and which are well worth discussing in detail.

4. Stats: More thoughts on equipoise (January 17, 2005). Vital to the ethical conduct of a clinical trial is the concept of equipoise, that a researcher is clinically indifferent or genuinely uncertain, as to whether a new therapy is better than the standard therapy.

3. Stats: The ethics of randomization (January 14, 2005). A recently published article, Treatment at random: the ultimate science or the betrayal of Hippocrates? Retsas S. J Clin Oncol 2004: 22(24); 5005-8; discussion 5009-11, attacks the randomized trial and declares it to be "a deficient research tool both on deontologic and methodologic grounds."


2. Stats: Alternatives to equipoise (November 24, 2004). Stephen Senn wrote an interesting article a couple of years ago that provides an intriguing alternative to the concept of equipoise. I wrote about equipoise in a web page discussing the ethics of placebo controlled trials. The concept of equipoise actually extends well beyond placebo controlled trials, but it is in those trials that the concept is most easily understood.

1. Stats: Adaptive randomization (July 15, 2004). Someone on the IRBForum posed a theoretical question. Is running a three arm study troublesome from an ethical viewpoint because the probability that any subject in the trial receives the best possible treatment decreases from 50% to 33%?

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