Blog
About

  • Record: found
  • Abstract: found
  • Article: not found

Ethics of randomised controlled trials – not yet time to give up on equipoise

, 1

Arthritis Research & Therapy

BioMed Central

design bias, ethical principles, expected outcomes, randomised controlled trials

Read this article at

ScienceOpenPublisherPMC
Bookmark
      There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

      Abstract

      In this commentary on Fries and Krishnan's argument that 'design bias' undermines the status of equipoise as the ethical justification for randomised controlled trials, it is argued that their argument is analogous to Bayesian arguments for the use of informative priors in trial design, but that this does not undermine the importance of equipoise. In particular, mismatches between the outcomes of interest to industrial sponsors of research and outcomes of interest to patients and clinicians ensure that in many cases industry-sponsored trials can fail to reflect the reasonable equipoise of working clinicians.

      Related collections

      Most cited references 21

      • Record: found
      • Abstract: found
      • Article: not found

      Equipoise and the ethics of clinical research.

      The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials because of the failure to enroll enough patients. I suggest an alternative concept of equipoise, which would be based on present or imminent controversy in the clinical community over the preferred treatment. According to this concept of "clinical equipoise," the requirement is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferred treatment.
        Bookmark
        • Record: found
        • Abstract: found
        • Article: not found

        Relation between agendas of the research community and the research consumer.

         P. Dieppe,  J Chard,  D Tallon (2000)
        Previous studies have suggested that research agendas can be biased. To determine whether there is a mismatch between available research evidence and the research preferences of consumers we examined research on interventions for the treatment of osteoarthritis of the knee joint. We searched published and unpublished studies on interventions in this condition to assess the structure of the evidence base. Focus groups and a postal survey of research consumers were then undertaken to examine their views and research priorities. Review of published and unpublished reports showed that the evidence base was dominated by studies of pharmaceutical (550, 59%) and surgical (238, 26%) interventions. 24 (36%) of 67 survey respondents ranked knee replacement as the highest priority for research, whereas 14 (21%) chose education and advice as their first choice. There is a mismatch between the amount of published work on different interventions, and the degree of interest of consumers. We suggest that broadening of the research agenda would be more in line with current treatment patterns and consumer views. If this mismatch is not addressed, then evidence-based medicine will not be representative of consumer needs.
          Bookmark
          • Record: found
          • Abstract: found
          • Article: not found

          The uncertainty principle and industry-sponsored research.

          Reporting of pharmaceutical-industry-sponsored randomised clinical trials often result in biased findings, either due to selective reporting of studies with non-equivalent arms or publication of low-quality papers, wherein unfavourable results are incompletely described. A randomised trial should be conducted only if there is substantial uncertainty about the relative value of one treatment versus another. Studies in which intervention and control are thought to be non-equivalent violates the uncertainty principle. We examined the quality of 136 published randomised trials that focused on one disease category (multiple myeloma) and adherence to the uncertainty principle. To evaluate whether the uncertainty principle was upheld, we compared the number of studies favouring experimental treatments over standard ones. We analysed data according to the source of funding. Trials funded solely or in part by 35 profit-making organisations had a trend toward higher quality scores (mean 2.94 [SD 1.3]; median 3) than randomised trials supported by 95 governmental or other non-profit organisations (2.4 [0.8]; 2; p=0.06). Overall, the uncertainty principle was upheld, with 44% of randomised trials favouring standard treatments and 56% innovative treatments (p=0.17); mean and median preference evaluation scores were 3.7 (1.0) and 4. However, when the analysis was done according to the source of funding, studies funded by non-profit organisations maintained equipoise favouring new therapies over standard ones (47% vs 53%; p=0.608) to a greater extent than randomised trials supported solely or in part by profit-making organisations (74% vs 26%; p=0.004). The reported bias in research sponsored by the pharmaceutical industry may be a consequence of violations of the uncertainty principle. Sponsors of clinical trials should be encouraged to report all results and to choose appropriate comparative controls.
            Bookmark

            Author and article information

            Affiliations
            [1 ]Medical Ethics Unit, Imperial College London, London, UK
            Contributors
            Journal
            Arthritis Res Ther
            Arthritis Research & Therapy
            BioMed Central (London )
            1478-6354
            1478-6362
            2004
            14 September 2004
            : 6
            : 6
            : 237-239
            1064870
            ar1442
            15535836
            10.1186/ar1442
            Copyright © 2004 BioMed Central Ltd
            Categories
            Commentary

            Comments

            Comment on this article