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- W2107071508 abstract "A systematic review of the literature on the ethics of clinical trials confirmed that “underpowered” trials are generally regarded as unethical. We argue that not only has this conclusion been rendered untenable by the rising acceptance of amalgamated evidence from many studies, but it was never based on sound premises. The idea that patients are misused if studies are underpowered is based on the false premise that such patients are disadvantaged to no avail. However, if the study is equipoised patients do not stand to lose out. Furthermore, imprecise results are better than no results at all, provided that statistics are not used to dichotomise the outcome data into positive and negative. Bayesian methods can formally model non-trial information and surrogate outcomes into the analysis, enhancing the overall value of an imprecise measurement of main effect. Our argument has two crucial caveats: small trials, if they are competing with large trials for transferable resources, might be a worse buy; and trials, whether small or large, must be of good quality and must make data available for posterity. This might be ensured by the organisation of trials through experienced trials offices. DEPARTMENT OF ERRORWhy “underpowered” trials are not necessarily unethical—In this viewpoint by S J L Edwards and colleagues (Sept 13, pp 804–07), the seventh sentence of the “Ethical argument” (p 806) was duplicated text and should not have appeared. Also, the concept of equipoise was misrepresented at some points in the text. Equipoise is not a property of the study or the treatments in a trial, but of individual patients. Different patients, even with identical beliefs about the likely affects of alternative treatments, will not generally have identical views about the relative benefit of the treatments. Full-Text PDF" @default.
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- W2107071508 title "Why “underpowered” trials are not necessarily unethical" @default.
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- W2107071508 doi "https://doi.org/10.1016/s0140-6736(97)02290-3" @default.
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