Strategies for power calculations in predictive biomarker studies in survival data.

ABSTRACT:

Purpose

Biomarkers and genomic signatures represent potentially predictive tools for precision medicine. Validation of predictive biomarkers in prospective or retrospective studies requires statistical justification of power and sample size. However, the design of these studies is complex and the statistical methods and associated software are limited, especially in survival data. Herein, we address common statistical design issues relevant to these two types of studies and provide guidance and a general template for analysis.

Methods

A statistical interaction effect in the Cox proportional hazards model is used to describe predictive biomarkers. The analytic form by Peterson et al. and Lachin is utilized to calculate the statistical power for both prospective and retrospect

SUBMITTER: Chen DT 

PROVIDER: S-EPMC5348326 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature