Parametrization of Survival Measures (Part II): Single Arm Studies

Abstract

In some clinical applications in oncology randomized, double armed, and double-blind trials are not possible. In case of device applications, double-blinded conditions are nonrealistic, and with many times the randomization also has complications due to the high-line treatments where the reference cohort is not available; the active “arm” has mainly palliative initiative. Sometimes highly personalized therapies block the collection of the homogeneous group and limit its double-arm randomization. Our objective is to discuss the situations of the single arm evaluation and to give methods for the mining of information from this to increase the level of evidence of the measured dataset. The basic idea of the data-separation is the appropriate parameterization of the non-parametric Kaplan-Meier survival pattern by the poly-Weibull fit.