Journal article
Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
- Abstract:
- Randomised controlled trials often use surrogate endpoints to substitute for a target outcome (an outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve efficiency (through shortened duration of follow-up, reduced sample size, and lower research costs), and for ethical or practical reasons. However, their use has a fundamental limitation in terms of uncertainty of the intervention effect on the target outcome and limited information on potential intervention harms. There have been increasing calls for improved reporting of trial protocols that use surrogate endpoints. This report presents the SPIRIT-Surrogate, an extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist, a consensus driven reporting guideline designed for trial protocols using surrogate endpoints as the primary outcome(s). The SPIRIT-Surrogate extension includes nine items modified from the SPIRIT 2013 checklist. The guideline provides examples and explanations for each item. We recommend that all stakeholders (including trial investigators and sponsors, research ethics reviewers, funders, journal editors, and peer reviewers) use this extension in reporting trial protocols that use surrogate endpoints. Its use will allow for improved design of such trials, improved transparency, and interpretation of findings when trials are completed, and ultimately reduced research waste.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 296.6KB, Terms of use)
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- Publisher copy:
- 10.1136/bmj-2023-078525
Authors
+ Cancer Research UK
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- Funder identifier:
- https://ror.org/054225q67
- Grant:
- 27294
- Publisher:
- BMJ Publishing Group
- Journal:
- British Medical Journal More from this journal
- Volume:
- 386
- Article number:
- e078525
- Place of publication:
- England
- Publication date:
- 2024-07-09
- Acceptance date:
- 2024-04-30
- DOI:
- EISSN:
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0959-8138
- ISSN:
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1759-2151
- Pmid:
-
38981624
- Language:
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English
- Keywords:
- Pubs id:
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2015543
- Local pid:
-
pubs:2015543
- Deposit date:
-
2025-03-17
- ARK identifier:
Terms of use
- Copyright holder:
- Manyara et al
- Copyright date:
- 2024
- Rights statement:
- © the Author(s) 2024. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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