Surrogate endpoints in trials: a call for better reporting

Oriana Ciani; Anthony M Manyara; An-Wen Chan; Rod S Taylor; SPIRIT-SURROGATE/CONSORT-SURROGATE project group

doi:10.1186/s13063-022-06904-7

Surrogate endpoints in trials: a call for better reporting

Trials. 2022 Dec 12;23(1):991. doi: 10.1186/s13063-022-06904-7.

Authors

Oriana Ciani¹, Anthony M Manyara², An-Wen Chan³, Rod S Taylor⁴; SPIRIT-SURROGATE/CONSORT-SURROGATE project group

Affiliations

¹ SDA Bocconi School of Management, Milan, Italy.
² MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
³ Women's College Institute Research Institute and Department of Medicine, University of Toronto, Toronto, Canada.
⁴ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley St, Glasgow, G3 7HR, Scotland, UK. rod.taylor@glasgow.ac.uk.

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.

Keywords: Randomised trials; Surrogate endpoints.

Publication types

Letter

MeSH terms

Humans
Reference Standards
Research Design*
Treatment Outcome

Grants and funding

MR/V038400/1/MRC_/Medical Research Council/United Kingdom