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Abstract:
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For immunotherapies, it may take some time for the treatment to show an effect due to its working mechanism: It does not work directly on tumor cells, but rather trains the immune system to fight the tumor cells. This so-called delayed effect may complicate the study design and evaluation of the treatment effect. Our discussion will focus on the impact it has on interim futility analysis. We will discuss methodologies to adjust futility boundaries, timing of the futility analysis, the impact of loss to follow up on the analysis, etc.
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