2024

Taylor, R. S. , Manyara, A. M. , Ross, J. S. and Ciani, O. (2024) Surrogate end points in trials—SPIRIT and CONSORT extensions. JAMA: Journal of the American Medical Association, (doi: 10.1001/jama.2024.15219) (PMID:39102315) (Early Online Publication)

Manyara, A. M. , Purvis, A., Ciani, O., Collins, G. S. and Taylor, R. S. (2024) Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilise? Journal of Clinical Epidemiology, (doi: 10.1016/j.jclinepi.2024.111485) (PMID:39069013) (In Press)

Manyara, A. M., Ciani, O. and Taylor, R. (2024) Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-and CONSORT-Surrogate extensions. Lancet, (doi: 10.1016/S0140-6736(24)01306-0) (PMID:39004089) (Early Online Publication)

Richert, L., Manyara, A. , Ciani, O. and Taylor, R. (2024) Présentation des Critères de Substitution dans les Publications d'Essais Contrôlés Randomisés: Élaboration et Explication de l'Extension CONSORT-Surrogate 202323. EPICLIN 2024, 18ème Conférence francophone d’Épidémiologie Clinique, 31èmes journées des statisticiens des centres de lutte contre le cancer, Dijon, France, 15-17 May 2024. p. 202444. (doi: 10.1016/j.jeph.2024.202444)

Christensen, R., Ciani, O., Manyara, A. M. and Taylor, R. S. (2024) Low-density lipoprotein cholesterol is not a successful surrogate endpoint: author’s reply. Journal of Clinical Epidemiology, 171, 111389. (doi: 10.1016/j.jclinepi.2024.111389) (PMID:38723781)

Wallach, J. D., Yoon, S., Doernberg, H., Glick, L. R., Ciani, O., Taylor, R. S. , Mooghali, M., Ramachandran, R. and Ross, J. S. (2024) Associations between surrogate markers and clinical outcomes for nononcologic chronic disease treatments. JAMA: Journal of the American Medical Association, 331(19), pp. 1646-1654. (doi: 10.1001/jama.2024.4175) (PMID:38648042)

2023

Ciani, O. et al. (2023) A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine, 65, 102283. (doi: 10.1016/j.eclinm.2023.102283) (PMID:37877001) (PMCID:PMC10590868)

Manyara, A. M. et al. (2023) Definitions, acceptability, limitations, and guidance in the use and reporting of surrogate endpoints in trials: a scoping review. Journal of Clinical Epidemiology, 160, pp. 83-99. (doi: 10.1016/j.jclinepi.2023.06.013) (PMID:37380118)

2022

Ciani, O., Manyara, A. M. , Chen, A.-W. and Taylor, R. S. (2022) Surrogate endpoints in trials: a call for better reporting. Trials, 23, 991. (doi: 10.1186/s13063-022-06904-7) (PMID:36503559) (PMCID:PMC9743760)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Surrogate endpoints in cardio-thoracic trials: a call for better reporting and improved interpretation of trial findings. European Journal of Cardio-Thoracic Surgery, 62(4), ezac449. (doi: 10.1093/ejcts/ezac449) (PMID:36112148)

Manyara, A. , Davies, P., Stewart, D., Wells, V. , Weir, C., Young, A., Taylor, R. and Ciani, O. (2022) Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol. BMJ Open, 12(10), e062798. (doi: 10.1136/bmjopen-2022-062798) (PMID:36229145) (PMCID:PMC9562307)

Manyara, A. M. et al. (2022) Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open, 12(10), e064304. (doi: 10.1136/bmjopen-2022-064304) (PMID:36220321) (PMCID:PMC9557267)

Ciani, O., Grigore, B. and Taylor, R. S. (2022) Development of a framework and decision tool for the evaluation of health technologies based on surrogate endpoint evidence. Health Economics, 31(S1), pp. 44-72. (doi: 10.1002/hec.4524) (PMID:35608044) (PMCID:PMC9546394)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Need for better reporting of trials with surrogate endpoints – SPIRIT|CONSORT-SURROGATE extensions. Journal of Epidemiology and Community Health, 76(9), pp. 769-770. (doi: 10.1136/jech-2022-219294) (PMID:35750481) (PMCID:PMC9380472)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Surrogate endpoints in trials – a call for better reporting. British Medical Journal, 378, o1912. (doi: 10.1136/bmj.o1912) (PMID:35905986)

Manyara, A. M. , Ciani, O. and Taylor, R. S. (2022) A call for better reporting of trials using surrogate primary endpoints. Alzheimer's and Dementia: Translational Research and Clinical Interventions, 8(1), e12340. (doi: 10.1002/trc2.12340) (PMID:35910671) (PMCID:PMC9323346)

Manyara, A. M. , Ciani, O. and Taylor, R. S. (2022) Reply to Commentary by Cummings (2022): Surrogate endpoints extend beyond biomarkers. Alzheimer's and Dementia, 8(1), e12344. (doi: 10.1002/trc2.12344) (PMID:35910664) (PMCID:PMC9323349)

Articles

Taylor, R. S. , Manyara, A. M. , Ross, J. S. and Ciani, O. (2024) Surrogate end points in trials—SPIRIT and CONSORT extensions. JAMA: Journal of the American Medical Association, (doi: 10.1001/jama.2024.15219) (PMID:39102315) (Early Online Publication)

Manyara, A. M. , Purvis, A., Ciani, O., Collins, G. S. and Taylor, R. S. (2024) Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilise? Journal of Clinical Epidemiology, (doi: 10.1016/j.jclinepi.2024.111485) (PMID:39069013) (In Press)

Manyara, A. M., Ciani, O. and Taylor, R. (2024) Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-and CONSORT-Surrogate extensions. Lancet, (doi: 10.1016/S0140-6736(24)01306-0) (PMID:39004089) (Early Online Publication)

Christensen, R., Ciani, O., Manyara, A. M. and Taylor, R. S. (2024) Low-density lipoprotein cholesterol is not a successful surrogate endpoint: author’s reply. Journal of Clinical Epidemiology, 171, 111389. (doi: 10.1016/j.jclinepi.2024.111389) (PMID:38723781)

Wallach, J. D., Yoon, S., Doernberg, H., Glick, L. R., Ciani, O., Taylor, R. S. , Mooghali, M., Ramachandran, R. and Ross, J. S. (2024) Associations between surrogate markers and clinical outcomes for nononcologic chronic disease treatments. JAMA: Journal of the American Medical Association, 331(19), pp. 1646-1654. (doi: 10.1001/jama.2024.4175) (PMID:38648042)

Ciani, O. et al. (2023) A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine, 65, 102283. (doi: 10.1016/j.eclinm.2023.102283) (PMID:37877001) (PMCID:PMC10590868)

Manyara, A. M. et al. (2023) Definitions, acceptability, limitations, and guidance in the use and reporting of surrogate endpoints in trials: a scoping review. Journal of Clinical Epidemiology, 160, pp. 83-99. (doi: 10.1016/j.jclinepi.2023.06.013) (PMID:37380118)

Ciani, O., Manyara, A. M. , Chen, A.-W. and Taylor, R. S. (2022) Surrogate endpoints in trials: a call for better reporting. Trials, 23, 991. (doi: 10.1186/s13063-022-06904-7) (PMID:36503559) (PMCID:PMC9743760)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Surrogate endpoints in cardio-thoracic trials: a call for better reporting and improved interpretation of trial findings. European Journal of Cardio-Thoracic Surgery, 62(4), ezac449. (doi: 10.1093/ejcts/ezac449) (PMID:36112148)

Manyara, A. , Davies, P., Stewart, D., Wells, V. , Weir, C., Young, A., Taylor, R. and Ciani, O. (2022) Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol. BMJ Open, 12(10), e062798. (doi: 10.1136/bmjopen-2022-062798) (PMID:36229145) (PMCID:PMC9562307)

Manyara, A. M. et al. (2022) Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open, 12(10), e064304. (doi: 10.1136/bmjopen-2022-064304) (PMID:36220321) (PMCID:PMC9557267)

Ciani, O., Grigore, B. and Taylor, R. S. (2022) Development of a framework and decision tool for the evaluation of health technologies based on surrogate endpoint evidence. Health Economics, 31(S1), pp. 44-72. (doi: 10.1002/hec.4524) (PMID:35608044) (PMCID:PMC9546394)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Need for better reporting of trials with surrogate endpoints – SPIRIT|CONSORT-SURROGATE extensions. Journal of Epidemiology and Community Health, 76(9), pp. 769-770. (doi: 10.1136/jech-2022-219294) (PMID:35750481) (PMCID:PMC9380472)

Ciani, O., Manyara, A. M. and Taylor, R. S. (2022) Surrogate endpoints in trials – a call for better reporting. British Medical Journal, 378, o1912. (doi: 10.1136/bmj.o1912) (PMID:35905986)

Manyara, A. M. , Ciani, O. and Taylor, R. S. (2022) A call for better reporting of trials using surrogate primary endpoints. Alzheimer's and Dementia: Translational Research and Clinical Interventions, 8(1), e12340. (doi: 10.1002/trc2.12340) (PMID:35910671) (PMCID:PMC9323346)

Manyara, A. M. , Ciani, O. and Taylor, R. S. (2022) Reply to Commentary by Cummings (2022): Surrogate endpoints extend beyond biomarkers. Alzheimer's and Dementia, 8(1), e12344. (doi: 10.1002/trc2.12344) (PMID:35910664) (PMCID:PMC9323349)

Conference or Workshop Item

Richert, L., Manyara, A. , Ciani, O. and Taylor, R. (2024) Présentation des Critères de Substitution dans les Publications d'Essais Contrôlés Randomisés: Élaboration et Explication de l'Extension CONSORT-Surrogate 202323. EPICLIN 2024, 18ème Conférence francophone d’Épidémiologie Clinique, 31èmes journées des statisticiens des centres de lutte contre le cancer, Dijon, France, 15-17 May 2024. p. 202444. (doi: 10.1016/j.jeph.2024.202444)