A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials.

ABSTRACT:

Background

Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials.

Methods

As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of s

SUBMITTER: Ciani O 

PROVIDER: S-EPMC10590868 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature