How to perform a cost-effectiveness analysis with surrogate endpoint: renal denervation in patients with resistant hypertension (DENERHTN) trial as an example by Julie Bulsei, Meryl Darlington, Isabelle Durand-Zaleski, Michel Azizi, The DENERHTN Study Group

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Comparing Bayesian hierarchical meta-regression methods and evaluating the influence of priors for evaluations of surrogate endpoints on heterogeneous collections of clinical trials by Willem Collier, Benjamin Haaland, Lesley A. Inker, Hiddo J.L. Heerspink, Tom Greene

Subjects: “…Surrogate endpoint…”
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Surrogate endpoints for overall survival in randomized clinical trials testing immune checkpoint inhibitors: a systematic review and meta-analysis by Isabella Sala, Isabella Sala, Eleonora Pagan, Laura Pala, Chiara Oriecuia, Chiara Oriecuia, Marco Musca, Marco Musca, Claudia Specchia, Tommaso De Pas, Javier Cortes, Javier Cortes, Javier Cortes, Giuseppe Giaccone, Michael Postow, Richard D. Gelber, Vincenzo Bagnardi, Fabio Conforti, Fabio Conforti

“…IntroductionThere is debate on which are the best surrogate endpoint and metric to capture treatment effect on overall survival (OS) in RCTs testing immune-checkpoint inhibitors (ICIs).MethodsWe systematically searched for RCTs testing ICIs in patients with advanced solid tumors. …”
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Bedside implications of the use of surrogate endpoints in solid and haematological cancers: implications for our reliance on PFS, DFS, ORR, MRD and more by Vinay Prasad, Alyson Haslam, Timothée Olivier, Dagney Ochoa, Eduardo Fernandez

“…Clinical endpoints, such as overall survival, directly measure relevant outcomes. Surrogate endpoints, in contrast, are intermediate, stand-in measures of various tumour-related metrics and include tumour growth, tumour shrinkage, blood results, etc. …”
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Intermediate endpoints as surrogates for outcomes in cancer immunotherapy: a systematic review and meta-analysis of phase 3 trialsResearch in context by Zhishan Zhang, Qunxiong Pan, Mingdong Lu, Bin Zhao

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Short-Term Relapse Quantitation as a Fully Surrogate Endpoint for Long-Term Sustained Progression of Disability in RRMS Patients Treated with Natalizumab by Y. C. Wang, A. Sandrock, J. R. Richert, L. Meyerson, X. Miao

“…A formal statistical validation of short-term relapse activity as a surrogate endpoint for long-term sustained progression of disability could potentially permit smaller, shorter, and less expensive clinical trials in RRMS. …”
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Evaluating glomerular filtration rate slope as a surrogate endpoint for ESKD in clinical trials: an individual participant meta-analysis of observational data by Grams, M, Sang, Y, Ballew, S, Woodward, M, al, E

Surrogacy of one-year survival for overall survival in advanced hepatocellular carcinoma by Yuzhi Jin, Hui Ren, Qianhua Yue, Wei Wu, Chuan Liu, Yixuan Guo, Peng Zhao

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Progression-free survival as surrogate endpoint of overall survival in esophageal squamous cell carcinoma: a real-world data and literature-based analysis by Weiming Han, Lan Wang, Chen Li, Junqiang Chen, Wencheng Zhang, Xin Wang, Qingsong Pang, Yidian Zhao, Xinchen Sun, Kaixian Zhang, Gaofeng Li, Ling Li, Xueying Qiao, Miaoling Liu, Yadi Wang, Lei Deng, Wenqing Wang, Nan Bi, Tao Zhang, Wei Deng, Wenjie Ni, Xiao Chang, Zongmei Zhou, Jun Liang, Qinfu Feng, Lvhua Wang, Dongfu Chen, Jima Lv, Shuchai Zhu, Chun Han, Zefen Xiao

“…This study aimed to determine the validity of PFS as a surrogate endpoint for OS in ESCC patients treated with definitive radiotherapy or definitive chemoradiotherapy (dRT/dCRT), as well as characterize the prognostic factors and survival of such patients. …”
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Radiation dose-response (a Bayesian model) in the radiotherapy of the localized prostatic adenocarcinoma: the reliability of PSA slope changes as a response surrogate endpoint by Reza Ali Mohammadpour, Jamshid Yazdani- Charati, SZahra Faghani, Ahad Alizadeh, Mohammadreza Barzegartahamtan

“…Therefore, although the absolute value of the PSA decreased with increasing doses of RT, the relationship between PSA slope changes and increasing doses was not clear and cannot be used as a reliable response surrogate endpoint.…”
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Identification on surrogating overall survival with progression-free survival of first-line immunochemotherapy in advanced esophageal squamous cell carcinoma—an exploration of surrogate endpoint by Zewei Zhang, Chunxia Xie, Tiantian Gao, Yuxian Yang, Yong Yang, Lei Zhao

“…However, to identify early efficacy and speed up drug approval, trials have used progression-free survival (PFS) as a surrogate endpoint (SE). Herein, we aimed to examine if PFS could function as an OS surrogate in advanced Esophageal Squamous Cell Carcinoma (ESCC) treated with first-line immunochemotherapy. …”
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Evaluation of the effectiveness of lipid-lowering agents by V. G. Shevko, M. A. Galas, T. L. Galankin, A. S. Kolbin

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Early Estimated Glomerular Filtration Rate Trajectories After Kidney Transplant Biopsy as a Surrogate Endpoint for Graft Survival in Late Antibody-Mediated Rejection by Anita Borski, Alexander Kainz, Nicolas Kozakowski, Heinz Regele, Johannes Kläger, Robert Strassl, Gottfried Fischer, Ingrid Faé, Sabine Wenda, Željko Kikić, Gregor Bond, Roman Reindl-Schwaighofer, Katharina A. Mayer, Michael Eder, Markus Wahrmann, Susanne Haindl, Konstantin Doberer, Georg A. Böhmig, Farsad Eskandary

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Correlation between surrogate endpoints and overall survival in unresectable hepatocellular carcinoma patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis by Litao Huang, Deying Kang, Chongyang Zhao, Xueting Liu

“…Correlations between OS and surrogate endpoints were evaluated using meta-regression analyses and calculating the surrogate threshold effect (STE). …”
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Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings by Tiantian Hua, Yuan Gao, Ruyang Zhang, Yongyue Wei, Feng Chen

Subjects: “…Surrogate endpoint…”
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Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting by Jong-Won Chung, Suk Jae Kim, Jaechun Hwang, Mi Ji Lee, Jun Lee, Kyung-Yul Lee, Man-Seok Park, Sang Min Sung, Keon Ha Kim, Pyoung Jeon, Oh Young Bang

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Measurable Residual Disease Assessment in Multiple Myeloma: How Deep Is Enough? by Joana Caetano, Filipa Barahona, Paulo Lúcio, Cristina João

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External validation of the IAIHG autoimmune hepatitis response criteria in a multicentric real-world cohort by Lorenz Grossar, Sarah Raevens, Christophe Van Steenkiste, Isabelle Colle, Charlotte De Vloo, Hans Orlent, Jeoffrey Schouten, Marie Gallant, Annelien Van Driessche, Sander Lefere, Lindsey Devisscher, Anja Geerts, Hans Van Vlierberghe, Xavier Verhelst

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A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial by Li Zhang, Pengfei Jin, Mingwei Wei, Hudachuan Jiang, Jingxin Li, Fengcai Zhu

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Correlation of multiple endpoints in the first‐line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials by Hiroyuki Arai, Madoka Takeuchi, Wataru Ichikawa, Kohei Shitara, Yu Sunakawa, Koji Oba, Wasaburo Koizumi, Yuh Sakata, Hiroshi Furukawa, Yasuhide Yamada, Masahiro Takeuchi, Masashi Fujii

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