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Abstract:
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Benefit-risk assessments for medical products involve all available information about the benefits and risks of a treatment that is often obtained through clinical trials. Benefit-risk assessments for medical products involve all available information about the benefits and risks of a treatment that is often obtained through clinical trials. A comprehensive benefit-risk determination should also take into account other factors reflecting the context in which these assessments are made. These factors include, among others, the uncertainty about the benefits and risks, the availability of alternative treatments, and the option of taking preliminary action and deferring a final benefit-risk determination to a later time, once more information is acquired. In particular, the value patients place on the treatment's benefit and their tolerance for risks and for the uncertainty on the benefits is a crucial factor. While the main challenge of benefit-risk determinations for medical product approval is to combine information with values, the essence of the Bayesian approach is to collect and update information, and merge it with values to make rational decisions. In this talk I will argue t
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