Spline-based procedures for dose-finding studies with active control.

ABSTRACT: In a dose-finding study with an active control, several doses of a new drug are compared with an established drug (the so-called active control). One goal of such studies is to characterize the dose-response relationship and to find the smallest target dose concentration d(*), which leads to the same efficacy as the active control. For this purpose, the intersection point of the mean dose-response function with the expected efficacy of the active control has to be estimated. The focus of this paper is a cubic spline-based method for deriving an estimator of the target dose without assuming a specific dose-response function. Furthermore, the construction of a spline-based bootstrap CI is described. Estimator and CI are compared with other flexible and parametric methods such as linear splin

SUBMITTER: Helms HJ 

PROVIDER: S-EPMC4288315 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature