Early termination of a two-stage study to develop and validate a panel of biomarkers.

ABSTRACT: Two-stage designs to develop and validate a panel of biomarkers present a natural setting for the inclusion of stopping rules for futility in the event of poor preliminary estimates of performance. We consider the design of a two-stage study to develop and validate a panel of biomarkers where a predictive model is developed using a subset of the samples in stage 1 and the model is validated using the remainder of the samples in stage 2. First, we illustrate how we can implement a stopping rule for futility in a standard, two-stage study for developing and validating a predictive model where samples are separated into a training sample and a validation sample. Simulation results indicate that our design has type I error rate and power similar to the fixed-sample design but with a substantia

SUBMITTER: Koopmeiners JS 

PROVIDER: S-EPMC3888241 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature