Statistical Methods to Evaluate Surrogate Markers.

ABSTRACT:

Background

There is tremendous interest in evaluating surrogate markers given their potential to decrease study time, costs, and patient burden.

Objectives

The purpose of this statistical workshop article is to describe and illustrate how to evaluate a surrogate marker of interest using the proportion of treatment effect (PTE) explained as a measure of the quality of the surrogate marker for: (1) a setting with a general fully observed primary outcome (eg, biopsy score); and (2) a setting with a time-to-event primary outcome which may be censored due to study termination or early drop out (eg, time to diabetes).

Methods

The methods are motivated by 2 randomized trials, one among children with nonalcoholic fatty liver disease where the primary outcome was a change in b

SUBMITTER: Parast L 

PROVIDER: S-EPMC10842261 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature