Abstract:
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In approving a product to treat cancer patients, the totality of information is considered. This information includes efficacy and safety results, availability of other treatment options, the population for which the treatment is intended, and other considerations. Both quantitative and qualitative data from different sources are synthesized in order to summarize the benefit and harm of the product that is being evaluated. In these type of synthesis, there are many challenges due to the objective and subjective nature of the components. In this presentation some of these challenges will be discussed.
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