2024
Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
Manyara A, Davies P, Stewart D, Weir C, Young A, Blazeby J, Butcher N, Bujkiewicz S, Chan A, Dawoud D, Offringa M, Ouwens M, Hróbjartsson A, Amstutz A, Bertolaccini L, Bruno V, Devane D, Faria C, Gilbert P, Harris R, Lassere M, Marinelli L, Markham S, Powers J, Rezaei Y, Richert L, Schwendicke F, Tereshchenko L, Thoma A, Turan A, Worrall A, Christensen R, Collins G, Ross J, Taylor R, Ciani O. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. The BMJ 2024, 386: e078524. PMID: 38981645, PMCID: PMC11231881, DOI: 10.1136/bmj-2023-078524.Peer-Reviewed Original ResearchConceptsRandomised controlled trial reportsTrial reportsRandomised controlled trialsControlled trial reportsIntervention treatment effectsResearch wasteTrial findingsTreatment effectsControlled trialsTarget outcomesChecklistAdequate informationSurrogate endpointsInterventionCONSORTItemsTrialsImprove transparencyHarmReportsGuidelinesOutcomesEndpoint
2023
Surrogate endpoints: a key concept in clinical epidemiology
Christensen R, Ciani O, Manyara A, Taylor R. Surrogate endpoints: a key concept in clinical epidemiology. Journal Of Clinical Epidemiology 2023, 167: 111242. PMID: 38142762, DOI: 10.1016/j.jclinepi.2023.111242.Peer-Reviewed Original ResearchPatient-important outcomesSurrogate endpointsClinical outcomesTrue clinical outcomeClinical trialsClinical epidemiologyRobust scientific evidenceHealth outcomesIntermediate outcomesEndpointMeaningful cutoffsScientific evidenceOutcomesTreatment effectsPatientsInterventionSpecific changesRigorous evaluationEpidemiologyTrialsBiomarkersSurrogacy and the Valuation of ATMPs: Taking Our Place in the Evidence Generation/Assessment Continuum
Gladwell D, Ciani O, Parnaby A, Palmer S. Surrogacy and the Valuation of ATMPs: Taking Our Place in the Evidence Generation/Assessment Continuum. PharmacoEconomics 2023, 42: 137-144. PMID: 37991631, DOI: 10.1007/s40273-023-01334-y.Peer-Reviewed Original ResearchAdvanced therapy medicinal productsTherapy medicinal productsSurrogate primary endpointTrial-level correlationSingle-arm studyMedicinal productsMechanism of actionHealth technology assessmentPrimary endpointPatient relevanceNovel interventionsAdvanced therapiesTreatment effectsEndpointTechnology assessmentSurrogacy relationshipsSurrogate relationshipsMedical technologyTherapyAdditional avenues