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Several approaches have been proposed for surrogate validation but available methods for validating a longitudinal biomarker as a surrogate of a time\u2010to\u2010event endpoint such as death remain limited. In this work, we propose a method for validating a longitudinal outcome as a surrogate of a time\u2010to\u2010event endpoint using a combination of joint modeling and mediation analysis. The proportion of the total treatment effect on the time\u2010to\u2010event endpoint due to its effect on the biomarker is used as a surrogacy measure. This method is developed to integrate meta\u2010analytic data using a joint model with random effects at both the individual and trial levels. From this model, the indirect treatment effect through the surrogate as well as the direct and total treatment effects is derived using a mediation formula. A simulation study was designed to evaluate the performance of this approach. We applied this method to a multicentric study on prostate cancer to investigate the use of prostate\u2010specific antigen level as a surrogate for disease\u2010free survival.<\/jats:p>","DOI":"10.1002\/bimj.70064","type":"journal-article","created":{"date-parts":[[2025,6,28]],"date-time":"2025-06-28T01:25:26Z","timestamp":1751073926000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Validation of a Longitudinal Marker as a Surrogate Using Mediation Analysis and Joint Modeling: Evolution of the PSA as a Surrogate of the Disease\u2010Free Survival"],"prefix":"10.1002","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6641-4199","authenticated-orcid":false,"given":"Quentin","family":"Le Coent","sequence":"first","affiliation":[{"name":"ISBA\/LIDAM UCLouvain  Louvain\u2010la\u2010Neuve Belgium"},{"name":"Department of Biostatistics Bordeaux Population Health Research Center INSERM U1219 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0461-5091","authenticated-orcid":false,"given":"Catherine","family":"Legrand","sequence":"additional","affiliation":[{"name":"ISBA\/LIDAM UCLouvain  Louvain\u2010la\u2010Neuve Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James J.","family":"Dignam","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences University of Chicago  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginie","family":"Rondeau","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Bordeaux Population Health Research Center INSERM U1219 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,27]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.11.4769"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280218808821"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.207"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/b138566"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/1.1.49"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxt051"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19970915)16:17<1965::AID-SIM630>3.0.CO;2-M"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6972"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.2002.00021.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780110204"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2003.11.023"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.9021"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1037\/a0020761"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1214\/10-STS321"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2008.01106.x"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.2307\/2534006"},{"key":"e_1_2_10_18_1","first-page":"1","article-title":"Tutorial in Joint Modeling and Prediction: A Statistical Software for Correlated Longitudinal Outcomes, Recurrent Events and a Terminal Event","volume":"81","author":"l A.","year":"2017","journal-title":"Journal of Statistical Software"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7640"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxac044"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7838"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1137\/0111030"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7220"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780080407"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxp009"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1080\/0266476022000023776"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.csda.2011.09.007"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1201\/b12208"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxl043"},{"key":"e_1_2_10_30_1","doi-asserted-by":"crossref","unstructured":"Rustand D. 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