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• W2289183742 abstract "Randomized controlled trials are the most praised form of clinical experimentation due to their generally acknowledged qualities of objectivity and external validity. In this context, the recent introduction of non-inferiority trials has raised the concern that this latter form of trial offers less epistemic warrants than the conventional superiority design. Indeed an operation which is crucial in non-inferiority trials is the choice of the non-inferiority margin, i.e. the range of tolerable inferiority of the new treatment face the standard used as the active control. This margin, which cannot be determined from objective references, but which rather depends on a complex interplay of objective data and contextual considerations, does in turn strongly affect the subsequent evaluation of the result of the NI trial. In my analysis I show how contextual factors play a role also in conventional superiority studies, in particular in the process of adapting the level of resolution of the study to the ethical and practical limitations posed by the participation of human patients to the clinical study. Furthermore, I discuss how such contextual considerations represent a necessary component in the process of devising a clinical trial for answering a concrete clinical question within a context where the available knowledge, the existing therapies, the nature of the illness and the situation of the patients both within and outside the trial all have to be taken into account." @default.
• W2289183742 created "2016-06-24" @default.
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• W2289183742 date "2015-01-01" @default.
• W2289183742 modified "2023-09-23" @default.
• W2289183742 title "Non Inferiority Drug Trials and the Trade-offs in RCTs" @default.
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• W2289183742 doi "https://doi.org/10.1007/978-3-319-23015-3_26" @default.
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