• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

随机临床试验中的替代终点和中间终点：目标是什么？

Surrogate and Intermediate Endpoints in Randomized Trials: What's the Goal?

机构信息

Biometric Research Program, National Cancer Institute, Bethesda, Maryland.

出版信息

Clin Cancer Res. 2018 May 15;24(10):2239-2240. doi: 10.1158/1078-0432.CCR-18-0183. Epub 2018 Feb 12.

DOI:10.1158/1078-0432.CCR-18-0183
PMID:29440189
Abstract

Establishing trial-level surrogacy of an intermediate endpoint for predicting survival benefit in future trials is extremely challenging because of the extrapolations required, but there are other useful drug development and patient management applications of intermediate endpoints. .

摘要

建立中间终点的试验级替代指标来预测未来试验中的生存获益极具挑战性，因为需要进行外推，但中间终点在药物开发和患者管理方面还有其他有用的应用。

相似文献

1
Surrogate and Intermediate Endpoints in Randomized Trials: What's the Goal?随机临床试验中的替代终点和中间终点：目标是什么？
Clin Cancer Res. 2018 May 15;24(10):2239-2240. doi: 10.1158/1078-0432.CCR-18-0183. Epub 2018 Feb 12.
2
Surrogacy of intermediate endpoints for overall survival in randomized controlled trials of first-line treatment for advanced soft tissue sarcoma in the pre- and post-pazopanib era: a meta-analytic evaluation.帕唑帕尼时代前后一线治疗晚期软组织肉瘤的随机对照试验中总生存期的中间终点替代：荟萃分析评估。
BMC Cancer. 2019 Jan 11;19(1):56. doi: 10.1186/s12885-019-5268-2.
3
Surrogate endpoints for overall survival in lung cancer trials: a review.肺癌试验中总生存期的替代终点：综述
Expert Rev Anticancer Ther. 2017 May;17(5):447-454. doi: 10.1080/14737140.2017.1316196. Epub 2017 Apr 12.
4
Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review.Meta 分析评估癌症随机试验中总生存的替代终点：批判性评价。
Crit Rev Oncol Hematol. 2018 Mar;123:21-41. doi: 10.1016/j.critrevonc.2017.11.014. Epub 2017 Nov 23.
5
surrosurv: An R package for the evaluation of failure time surrogate endpoints in individual patient data meta-analyses of randomized clinical trials.surrosurv：用于在随机临床试验个体患者数据荟萃分析中评估失效时间替代终点的 R 包。
Comput Methods Programs Biomed. 2018 Mar;155:189-198. doi: 10.1016/j.cmpb.2017.12.005. Epub 2017 Dec 13.
6
Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review.免疫检查点抑制剂和候选替代终点在多种肿瘤类型中的总生存期：系统文献回顾。
Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.
7
Endpoint surrogacy in oncology Phase 3 randomised controlled trials.肿瘤学 3 期随机对照试验中的替代终点。
Br J Cancer. 2020 Aug;123(3):333-334. doi: 10.1038/s41416-020-0896-5. Epub 2020 May 26.
8
The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.生物标志物替代评估方案：对生物标志物替代相关文献的综述以及关于用于评估生物标志物作为替代终点状态的基于标准、定量、多维度层次证据方案的提议。
Stat Methods Med Res. 2008 Jun;17(3):303-40. doi: 10.1177/0962280207082719. Epub 2007 Oct 9.
9
Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.癌症临床试验实例中的替代终点统计评估。
Biom J. 2016 Jan;58(1):104-32. doi: 10.1002/bimj.201400049. Epub 2015 Feb 12.
10
A new proportion measure of the treatment effect captured by candidate surrogate endpoints.候选替代终点所捕获的治疗效果的一种新的比例度量。
Stat Med. 2014 Aug 30;33(19):3338-53. doi: 10.1002/sim.6180. Epub 2014 Apr 29.

引用本文的文献

1
NRG-BR008/HERO study: a Phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer.NRG-BR008/HERO研究：一项针对低风险HER2阳性乳腺癌放疗优化的III期随机试验。
Future Oncol. 2025 Jul;21(16):2017-2025. doi: 10.1080/14796694.2025.2511586. Epub 2025 Jun 26.
2
Improving the efficiency of clinical trials in multiple sclerosis.提高多发性硬化症临床试验的效率。
Mult Scler. 2023 Aug;29(9):1136-1148. doi: 10.1177/13524585231189671.
3
Regulatory implications of ctDNA in immuno-oncology for solid tumors.
ctDNA 在实体瘤免疫肿瘤学中的监管意义。
J Immunother Cancer. 2023 Feb;11(2). doi: 10.1136/jitc-2022-005344.
4
Clinical Benefit Scales and Trial Design: Some Statistical Issues.临床获益量表与试验设计：一些统计学问题。
J Natl Cancer Inst. 2022 Sep 9;114(9):1222-1227. doi: 10.1093/jnci/djac099.
5
Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop.在膀胱癌根治术前对新辅助治疗临床试验设计进行精细化改良：美国食品和药物管理局与膀胱癌倡导网络联合研讨会。
Nat Rev Urol. 2022 Jan;19(1):37-46. doi: 10.1038/s41585-021-00505-w. Epub 2021 Sep 10.
6
A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses.一项关于使用荟萃分析报告替代终点评估的系统评价与建议
JNCI Cancer Spectr. 2019 Feb 6;3(1):pkz002. doi: 10.1093/jncics/pkz002. eCollection 2019 Mar.