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美国食品药品监督管理局对用于癌症药物批准的替代终点的认可：1992 - 2019年

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.

作者信息

Chen Emerson Y, Haslam Alyson, Prasad Vinay

机构信息

Knight Cancer Institute, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland.

Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland.

出版信息

JAMA Intern Med. 2020 Jun 1;180(6):912-914. doi: 10.1001/jamainternmed.2020.1097.

DOI:10.1001/jamainternmed.2020.1097
PMID:32338703
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7186918/
Abstract

This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.

摘要

这项回顾性研究评估了在癌症治疗中首次使用与后续使用替代指标的频率，以及替代指标与以患者为中心的结局的关联强度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38fb/7186918/672ad5f62725/jamainternmed-180-912-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38fb/7186918/672ad5f62725/jamainternmed-180-912-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38fb/7186918/672ad5f62725/jamainternmed-180-912-g001.jpg

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A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology.
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