Statistical methods for a phase II oncology trial with a growth modulation index (GMI) endpoint.


For cytostatic cancer therapies, alternatives to traditional phase II endpoints are needed. Von Hoff (1998) proposed an intrapatient progression-free survival (PFS) ratio, the growth modulation index (GMI). Current practice in estimation of the GMI success rate is conservative and omits a measure of uncertainty. We investigated nonparametric and parametric… (More)
DOI: 10.1016/j.cct.2010.09.010


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