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

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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.

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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 We searched published and unpublished studies on interventions in this condition to assess the structure of the evidence base.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 Review of published and unpublished reports showed that the evidence base was dominated by studies of pharmaceutical (550, 59%) and surgical (238, 26%) interventions. 24 (36%) of 67 survey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.

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The uncertainty principle and industry-sponsored research.

B Djulbegovic, M Lacevic, A Cantor … (2000)

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.