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However, the reported benefits of pembrolizumab in patients' quality of life (QoL) have been inconsistent across different studies and different types of cancer. As oncology drug development increasingly emphasizes patient\u2010centered care, patient\u2010reported outcomes (PROs), particularly patient\u2010reported QoL, are recognized as important clinical endpoints. To characterize the effects of pembrolizumab on patient\u2010reported QoL, we conducted a model\u2010based meta\u2010analysis (MBMA) of published clinical trials evaluating pembrolizumab across different types of cancer. The longitudinal EORTC QLQ\u2010C30 GHS\/QOL data were extracted in our analysis as QoL scores. A population model was developed to characterize the longitudinal QoL trajectories and quantify both treatment toxicity and efficacy. Out of more than 300 screened studies, only 20 reported longitudinal EORTC QLQ\u2010C30 QoL data. Among these, 8 studies reported no between\u2010group differences in QoL outcomes between pembrolizumab and control arms. However, our modeling revealed that pembrolizumab was associated with greater toxicity but improved long\u2010term QoL. Notably, our approach identified treatment effects on QoL that were not detected by traditional statistical analyses in the original publications. In summary, our study demonstrates that MBMA combined with population modeling enables more accurate evaluation of longitudinal PROs data, overcoming the limitations of conventional methods. This approach offers a robust framework for integrating patient\u2010centered outcomes into oncology drug development and supports the broader use of PROs data in regulatory and clinical decision\u2010making.<\/jats:p>","DOI":"10.1002\/psp4.70106","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T16:41:16Z","timestamp":1759250476000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A Model\u2010Based Meta\u2010Analysis of Pembrolizumab Effects on Patient\u2010Reported Quality of Life: Advancing Patient\u2010Centered Oncology Drug Development"],"prefix":"10.1002","volume":"15","author":[{"given":"Yiqin","family":"Zou","sequence":"first","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy, University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yimeng","family":"Sun","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy, University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudhamshu","family":"Ravva","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy, University of North Carolina  Chapel Hill North Carolina USA"},{"name":"Princeton International School of Mathematics and Science  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9685-4796","authenticated-orcid":false,"given":"Lynne I.","family":"Wagner","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3317-0311","authenticated-orcid":false,"given":"Jiawei","family":"Zhou","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics Eshelman School of Pharmacy, University of North Carolina  Chapel Hill North Carolina USA"},{"name":"Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"Prioritizing Patient\u2010Centered Care in a World of Increasingly Advanced Technologies and Disconnected Care","year":"2024"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1611252"},{"key":"e_1_2_11_4_1","first-page":"347","volume-title":"How Vital Are Patient\u2010Reported Outcomes","author":"Chang S. 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