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Abstract:
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Graphical testing procedure is applied in a hypothetical seamless phase II/III oncology study that has progression free survival (PFS) and overall survival (OS) as co-primary endpoints with an interim analysis on OS. The full alpha is split between PFS and OS, with an alpha spending function applied in the sequential testing for OS. We show that this design can be formulated in the framework of Bretz et al. (2009), a graphical approach to sequentially rejective multiple test procedures, although the initial alpha allocation and the propagation weights depend on the number of OS events at the interim analysis.
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