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Switch to: References
Citations of:
A case for Bayesianism in clinical trials (with discussion)
Statistics in Medicine 12 (15-16):1377-1393 (1993)
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The data analyzed in this paper are part of the results described in Bueno et al. (2000). Three cytogenetics endpoints were analyzed in three populations of a species of wild rodent – Akodon montensis – living in an industrial, an agricultural, and a preservation area at the Itajaí Valley, State of Santa Catarina, Brazil. The polychromatic/normochromatic ratio, the mitotic index, and the frequency of micronucleated polychromatic erythrocites were used in an attempt to establish a genotoxic profile of each area. It (...) |
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The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) |
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This paper outlines the approaches of two apparently competing schools of statistics. The criticisms made by supporters of Bayesian statistics about conventional Frequentist statistics are explained, and the Bayesian claim that their method enables research into new treatments without the need for clinical trials is examined in detail. Several further important issues are considered, including: the use of historical controls and data routinely collected on patients; balance in randomised trials; the possibility of giving information to patients; patient choice and patient (...) |
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A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are (...) |
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In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon who identified the CONSORT statement as a schema that would have, had it existed at the time, ruled out the design of the Salk polio vaccine trial of 1954 in favor of a completely randomized controlled clinical trial. We (...) |
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Increasingly, clinical research is evaluated on the quality of its statistical analysis. Traditionally, statistical analyses in clinical research have been carried out from a ‘frequentist’ perspective. The presence of an alternative paradigm – the Bayesian paradigm – has been relatively unknown in clinical research until recently. There is currently a growing interest in the use of Bayesian statistics in health care research. This is due both to a growing realization of the limitations of frequentist methods and to the ability of (...) |
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