Authors
Oriana Ciani, Anthony M Manyara, Philippa Davies, Derek Stewart, Christopher J Weir, Amber E Young, Jane Blazeby, Nancy J Butcher, Sylwia Bujkiewicz, An-Wen Chan, Dalia Dawoud, Martin Offringa, Mario Ouwens, Asbjørn Hróbjartssson, Alain Amstutz, Luca Bertolaccini, Vito Domenico Bruno, Declan Devane, Christina DCM Faria, Peter B Gilbert, Ray Harris, Marissa Lassere, Lucio Marinelli, Sarah Markham, John H Powers, Yousef Rezaei, Laura Richert, Falk Schwendicke, Larisa G Tereshchenko, Achilles Thoma, Alparslan Turan, Andrew Worrall, Robin Christensen, Gary S Collins, Joseph S Ross, Rod S Taylor
Publication date
2023/11/1
Journal
eClinicalMedicine
Volume
65
Publisher
Elsevier
Description
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 surrogate endpoints as primary outcome measures in trials.
Findings
Current surrogate endpoint definitional frameworks are inconsistent …
Total citations
20244
Scholar articles
O Ciani, AM Manyara, P Davies, D Stewart, CJ Weir… - EClinicalMedicine, 2023