• 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

当代癌症 III 期随机对照试验中具有时间事件结局的统计检验/估计方法。

Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes.

机构信息

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

出版信息

Oncologist. 2020 Feb;25(2):91-93. doi: 10.1634/theoncologist.2019-0464. Epub 2019 Nov 19.

DOI:10.1634/theoncologist.2019-0464
PMID:32043795
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7011662/
Abstract

There exist a wide variety of statistical methods for clinical trials. Despite decades of clinical trial research, little is known about which methods are used in data analysis practice of the real world. This review describes the evidence of existing practices on survival data analysis and identifies potential opportunities to improve them.

摘要

临床试验中存在着各种各样的统计方法。尽管已经进行了几十年的临床试验研究,但对于在现实世界的数据分析实践中使用哪些方法,人们知之甚少。本综述描述了生存数据分析中现有实践的证据,并确定了改进这些实践的潜在机会。

相似文献

1
Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes.当代癌症 III 期随机对照试验中具有时间事件结局的统计检验/估计方法。
Oncologist. 2020 Feb;25(2):91-93. doi: 10.1634/theoncologist.2019-0464. Epub 2019 Nov 19.
2
Empirical power comparison of statistical tests in contemporary phase III randomized controlled trials with time-to-event outcomes in oncology.肿瘤学中以时间为事件的当代 III 期随机对照试验中统计检验的经验功效比较。
Clin Trials. 2020 Dec;17(6):597-606. doi: 10.1177/1740774520940256. Epub 2020 Sep 15.
3
Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint.具有事件发生时间终点的随机II期研究中的定量决策
J Biopharm Stat. 2019;29(1):189-202. doi: 10.1080/10543406.2018.1489400. Epub 2018 Jul 3.
4
Interval and point estimation in adaptive Phase II trials with binary endpoint.具有二元终点的适应性II期试验中的区间估计和点估计。
Stat Methods Med Res. 2019 Sep;28(9):2635-2648. doi: 10.1177/0962280218781411. Epub 2018 Jun 19.
5
Interim analysis of binary outcome data in clinical trials: a comparison of five estimators.临床试验中二元结局数据的期中分析:五种估计量的比较
J Biopharm Stat. 2019;29(2):400-410. doi: 10.1080/10543406.2018.1559852. Epub 2019 Jan 1.
6
Covariate adjustment for randomized controlled trials revisited.再次探讨随机对照试验的协变量调整。
Pharm Stat. 2020 May;19(3):255-261. doi: 10.1002/pst.1988. Epub 2019 Dec 21.
7
Integrating phase 2 into phase 3 based on an intermediate endpoint while accounting for a cure proportion-With an application to the design of a clinical trial in acute myeloid leukemia.基于一个中间终点将2期纳入3期,同时考虑治愈率——应用于急性髓系白血病的一项临床试验设计
Pharm Stat. 2020 Jan;19(1):44-58. doi: 10.1002/pst.1969. Epub 2019 Aug 28.
8
Estimation of treatment effect in two-stage confirmatory oncology trials of personalized medicines.个性化药物两阶段确证性肿瘤学试验中治疗效果的评估。
Stat Med. 2017 May 30;36(12):1843-1861. doi: 10.1002/sim.7272. Epub 2017 Mar 17.
9
Comparison of Time-to-First Event and Recurrent-Event Methods in Randomized Clinical Trials.随机临床试验中首次事件时间和复发性事件方法的比较。
Circulation. 2018 Aug 7;138(6):570-577. doi: 10.1161/CIRCULATIONAHA.117.033065.
10
An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints.一种用于肿瘤学试验的适应性无缝II/III期设计,该设计使用相关生存终点进行亚组选择。
Pharm Stat. 2011 Jul-Aug;10(4):347-56. doi: 10.1002/pst.472. Epub 2010 Dec 8.

引用本文的文献

1
On Sample Size Determination for Augmented Tests Based on Restricted Mean Survival Time in Randomized Clinical Trials.基于随机临床试验中受限平均生存时间的增强检验的样本量确定
Biom J. 2025 Apr;67(2):e70046. doi: 10.1002/bimj.70046.
2
Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis.肿瘤标志物:生物标志物驱动研究和统计分析中的复杂性。
JCO Precis Oncol. 2024 Jul;8:e2400358. doi: 10.1200/PO.24.00358.
3
Regression models for average hazard.平均风险的回归模型。
Biometrics. 2024 Mar 27;80(2). doi: 10.1093/biomtc/ujae037.
4
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails.生存曲线具有发散尾部时受限平均生存时间的敏感性分析
Ther Innov Regul Sci. 2023 May;57(3):467-471. doi: 10.1007/s43441-022-00484-z. Epub 2023 Jan 3.
5
Optimal two-stage designs based on restricted mean survival time for a single-arm study.基于单臂研究受限平均生存时间的最优两阶段设计。
Contemp Clin Trials Commun. 2021 Jan 23;21:100732. doi: 10.1016/j.conctc.2021.100732. eCollection 2021 Mar.

本文引用的文献

1
How Do the Accrual Pattern and Follow-Up Duration Affect the Hazard Ratio Estimate When the Proportional Hazards Assumption Is Violated?当比例风险假设不成立时,累积模式和随访持续时间如何影响危害比的估计?
Oncologist. 2019 Jul;24(7):867-871. doi: 10.1634/theoncologist.2018-0141. Epub 2018 Sep 10.
2
Treatment effects measured by restricted mean survival time in trials of immune checkpoint inhibitors for cancer.免疫检查点抑制剂治疗癌症的临床试验中通过受限平均生存时间衡量的治疗效果。
Ann Oncol. 2018 May 1;29(5):1320-1324. doi: 10.1093/annonc/mdy075.
3
Cancer Biology and Survival Analysis in Cancer Trials: Restricted Mean Survival Time Analysis versus Hazard Ratios.癌症生物学与癌症试验中的生存分析:限制平均生存时间分析与风险比。
Clin Oncol (R Coll Radiol). 2018 Sep;30(9):e75-e80. doi: 10.1016/j.clon.2018.04.011.
4
Comparison of the restricted mean survival time with the hazard ratio in superiority trials with a time-to-event end point.在具有事件发生时间终点的优效性试验中,受限平均生存时间与风险比的比较。
Pharm Stat. 2018 May;17(3):202-213. doi: 10.1002/pst.1846. Epub 2017 Dec 28.
5
Restricted Mean Survival Time: An Obligatory End Point for Time-to-Event Analysis in Cancer Trials?受限平均生存时间:癌症试验中事件发生时间分析的必要终点?
J Clin Oncol. 2016 Oct 1;34(28):3474-6. doi: 10.1200/JCO.2016.67.8045. Epub 2016 Aug 9.
6
The Net Chance of a Longer Survival as a Patient-Oriented Measure of Treatment Benefit in Randomized Clinical Trials.作为随机临床试验中治疗效益的一种以患者为中心的衡量指标,净生存机会。
JAMA Oncol. 2016 Jul 1;2(7):901-5. doi: 10.1001/jamaoncol.2015.6359.
7
Describing Differences in Survival Curves.描述生存曲线的差异。
JAMA Oncol. 2016 Jul 1;2(7):906-7. doi: 10.1001/jamaoncol.2016.0001.
8
Comparison of Treatment Effects Measured by the Hazard Ratio and by the Ratio of Restricted Mean Survival Times in Oncology Randomized Controlled Trials.肿瘤学随机对照试验中风险比和受限平均生存时间比测量的治疗效果比较。
J Clin Oncol. 2016 May 20;34(15):1813-9. doi: 10.1200/JCO.2015.64.2488. Epub 2016 Feb 16.
9
Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies.非劣效性研究中用于比较治疗效果或安全性的风险比替代方法。
Ann Intern Med. 2015 Jul 21;163(2):127-34. doi: 10.7326/M14-1741.
10
Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis.超越风险比:在生存分析中量化组间差异。
J Clin Oncol. 2014 Aug 1;32(22):2380-5. doi: 10.1200/JCO.2014.55.2208. Epub 2014 Jun 30.