Surrogate endpoints in trials: a call for better reporting

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;...

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Autores principales: Ciani, Oriana, Manyara, Anthony M., Chan, An-Wen, Taylor, Rod S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743760/
https://www.ncbi.nlm.nih.gov/pubmed/36503559
http://dx.doi.org/10.1186/s13063-022-06904-7
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author Ciani, Oriana
Manyara, Anthony M.
Chan, An-Wen
Taylor, Rod S.
author_facet Ciani, Oriana
Manyara, Anthony M.
Chan, An-Wen
Taylor, Rod S.
author_sort Ciani, Oriana
collection PubMed
description 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.
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spelling pubmed-97437602022-12-13 Surrogate endpoints in trials: a call for better reporting Ciani, Oriana Manyara, Anthony M. Chan, An-Wen Taylor, Rod S. Trials Commentary 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. BioMed Central 2022-12-12 /pmc/articles/PMC9743760/ /pubmed/36503559 http://dx.doi.org/10.1186/s13063-022-06904-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Ciani, Oriana
Manyara, Anthony M.
Chan, An-Wen
Taylor, Rod S.
Surrogate endpoints in trials: a call for better reporting
title Surrogate endpoints in trials: a call for better reporting
title_full Surrogate endpoints in trials: a call for better reporting
title_fullStr Surrogate endpoints in trials: a call for better reporting
title_full_unstemmed Surrogate endpoints in trials: a call for better reporting
title_short Surrogate endpoints in trials: a call for better reporting
title_sort surrogate endpoints in trials: a call for better reporting
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743760/
https://www.ncbi.nlm.nih.gov/pubmed/36503559
http://dx.doi.org/10.1186/s13063-022-06904-7
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