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Surrogate endpoints in trials: a call for better reporting

Authors :
Oriana Ciani
Anthony M. Manyara
An-Wen Chan
Rod S. Taylor
on behalf of the SPIRIT-SURROGATE/CONSORT-SURROGATE project group
Source :
Trials, Vol 23, Iss 1, Pp 1-4 (2022)
Publication Year :
2022
Publisher :
BMC, 2022.

Abstract

Abstract Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.

Details

Language :
English
ISSN :
17456215
Volume :
23
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.509773a1aa7745d28395c37b446b56fc
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-022-06904-7