Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratifica...

Nosocomial Infections: The Definition Criteria

Hard, harder, hardest: principal stratification, statistical identifiability, and the inherent difficulty of finding surrogate endpoints

In many areas of clinical investigation there is great interest in identifying and validating surrogate endpoints, biomarkers that can be measured a relatively short time after a treatment has been administered and that can reliably predict the effect of treatment on the clinical outcome of interest. However, despite dramatic advances in the ability to measure biomarkers, the recent history of ...

An Introduction to Principal Surrogate Evaluation with the pseval Package.

We describe a new package called pseval that implements the core methods for the evaluation of principal surrogates in a single clinical trial. It provides a flexible interface for defining models for the risk given treatment and the surrogate, the models for integration over the missing counterfactual surrogate responses, and the estimation methods. Estimated maximum likelihood and pseudo-scor...

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal.

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21-29), we consider an approach that has a causal interpretation and develop...