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A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials

dc.rights.licenseopenen_US
dc.contributor.authorCIANI, Oriana
dc.contributor.authorMANYARA, Anthony M
dc.contributor.authorDAVIES, Philippa
dc.contributor.authorSTEWART, Derek
dc.contributor.authorWEIR, Christopher J
dc.contributor.authorYOUNG, Amber E
dc.contributor.authorBLAZEBY, Jane
dc.contributor.authorBUTCHER, Nancy J
dc.contributor.authorBUJKIEWICZ, Sylwia
dc.contributor.authorCHAN, An-Wen
dc.contributor.authorDAWOUD, Dalia
dc.contributor.authorOFFRINGA, Martin
dc.contributor.authorOUWENS, Mario
dc.contributor.authorHROBJARTSSSON, Asbjorn
dc.contributor.authorAMSTUTZ, Alain
dc.contributor.authorBERTOLACCINI, Luca
dc.contributor.authorBRUNO, Vito Domenico
dc.contributor.authorDEVANE, Declan
dc.contributor.authorFARIA, Christina D C M
dc.contributor.authorGILBERT, Peter B
dc.contributor.authorHARRIS, Ray
dc.contributor.authorLASSERE, Marissa
dc.contributor.authorMARINELLI, Lucio
dc.contributor.authorMARKHAM, Sarah
dc.contributor.authorPOWERS, John H
dc.contributor.authorREZAEI, Yousef
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorSCHWENDICKE, Falk
dc.contributor.authorTERESHCHENKO, Larisa G
dc.contributor.authorTHOMA, Achilles
dc.contributor.authorTURAN, Alparslan
dc.contributor.authorWORRALL, Andrew
dc.contributor.authorCHRISTENSEN, Robin
dc.contributor.authorCOLLINS, Gary S
dc.contributor.authorROSS, Joseph S
dc.contributor.authorTAYLOR, Rod S
dc.date.accessioned2024-01-10T13:03:46Z
dc.date.available2024-01-10T13:03:46Z
dc.date.issued2023-11
dc.identifier.issn2589-5370en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/187004
dc.description.abstractEnBACKGROUND: 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 and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators. INTERPRETATION: There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence. FUNDING: SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enSurrogate endpoints
dc.subject.enTarget outcomes
dc.subject.enIntermediate outcomes
dc.title.enA framework for the definition and interpretation of the use of surrogate endpoints in interventional trials
dc.title.alternativeEClinicalMedicineen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.eclinm.2023.102283en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37877001en_US
bordeaux.journalEClinicalMedicineen_US
bordeaux.page102283en_US
bordeaux.volume65en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04385165
hal.version1
hal.date.transferred2024-01-10T13:03:55Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=EClinicalMedicine&rft.date=2023-11&rft.volume=65&rft.spage=102283&rft.epage=102283&rft.eissn=2589-5370&rft.issn=2589-5370&rft.au=CIANI,%20Oriana&MANYARA,%20Anthony%20M&DAVIES,%20Philippa&STEWART,%20Derek&WEIR,%20Christopher%20J&rft.genre=article


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