Suppr超能文献

使用广义线性模型和广义线性模型在临床试验中纳入历史信息的相称先验。

Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models.

作者信息

Hobbs Brian P, Sargent Daniel J, Carlin Bradley P

机构信息

Department of Biostatistics, M.D. Anderson Cancer Center, Houston, TX, 77030, USA.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, 55905, USA.

出版信息

Bayesian Anal. 2012 Aug 28;7(3):639-674. doi: 10.1214/12-BA722.

Abstract

Assessing between-study variability in the context of conventional random-effects meta-analysis is notoriously difficult when incorporating data from only a small number of historical studies. In order to borrow strength, historical and current data are often assumed to be fully homogeneous, but this can have drastic consequences for power and Type I error if the historical information is biased. In this paper, we propose empirical and fully Bayesian modifications of the commensurate prior model (Hobbs et al., 2011) extending Pocock (1976), and evaluate their frequentist and Bayesian properties for incorporating patient-level historical data using general and generalized linear mixed regression models. Our proposed commensurate prior models lead to preposterior admissible estimators that facilitate alternative bias-variance trade-offs than those offered by pre-existing methodologies for incorporating historical data from a small number of historical studies. We also provide a sample analysis of a colon cancer trial comparing time-to-disease progression using a Weibull regression model.

摘要

在传统随机效应荟萃分析的背景下,当仅纳入少量历史研究的数据时,评估研究间变异性非常困难。为了增强效力,历史数据和当前数据通常被假定为完全同质,但如果历史信息存在偏差,这可能会对检验效能和I型错误产生严重影响。在本文中,我们提出了对相称先验模型(霍布斯等人,2011年)的实证和完全贝叶斯修正,扩展了波科克(1976年)的模型,并使用一般和广义线性混合回归模型评估其在纳入患者水平历史数据方面的频率主义和贝叶斯属性。我们提出的相称先验模型产生了后验可容许估计量,与现有纳入少量历史研究历史数据的方法相比,有助于实现不同的偏差 - 方差权衡。我们还提供了一个使用威布尔回归模型比较结肠癌试验中疾病进展时间的样本分析。

相似文献

2
Adaptive adjustment of the randomization ratio using historical control data.
Clin Trials. 2013;10(3):430-40. doi: 10.1177/1740774513483934.
4
Critical appraisal of Bayesian dynamic borrowing from an imperfectly commensurate historical control.
Pharm Stat. 2020 Sep;19(5):613-625. doi: 10.1002/pst.2018. Epub 2020 Mar 17.
5
Bayesian hypothesis testing with frequentist characteristics in clinical trials.
Contemp Clin Trials. 2019 Dec;87:105858. doi: 10.1016/j.cct.2019.105858. Epub 2019 Oct 24.
6
Elastic priors to dynamically borrow information from historical data in clinical trials.
Biometrics. 2023 Mar;79(1):49-60. doi: 10.1111/biom.13551. Epub 2021 Sep 20.
7
Including historical data in the analysis of clinical trials: Is it worth the effort?
Stat Methods Med Res. 2018 Oct;27(10):3167-3182. doi: 10.1177/0962280217694506. Epub 2017 Feb 21.
8
Addressing prior-data conflict with empirical meta-analytic-predictive priors in clinical studies with historical information.
J Biopharm Stat. 2016;26(6):1056-1066. doi: 10.1080/10543406.2016.1226324. Epub 2016 Aug 19.
9
Using horseshoe prior for incorporating multiple historical control data in randomized controlled trials.
Stat Methods Med Res. 2022 Jul;31(7):1392-1404. doi: 10.1177/09622802221090752. Epub 2022 Apr 5.
10
Historical controls in clinical trials: a note on linking Pocock's model with the robust mixture priors.
Biostatistics. 2023 Apr 14;24(2):443-448. doi: 10.1093/biostatistics/kxab040.

引用本文的文献

1
Radiation dose escalation in locally advanced oesophageal cancer: a systematic review and hierarchical Bayesian meta-analysis.
EClinicalMedicine. 2025 Aug 13;87:103432. doi: 10.1016/j.eclinm.2025.103432. eCollection 2025 Sep.
6
Borrowing using historical-bias power prior with empirical Bayes.
J Biopharm Stat. 2024 Dec 8:1-31. doi: 10.1080/10543406.2024.2429461.
7
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials.
Ther Innov Regul Sci. 2025 Jan;59(1):20-30. doi: 10.1007/s43441-024-00723-5. Epub 2024 Nov 21.
10
A Bayesian platform trial design with hybrid control based on multisource exchangeability modelling.
Stat Med. 2024 May 30;43(12):2439-2451. doi: 10.1002/sim.10077. Epub 2024 Apr 9.

本文引用的文献

1
Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials.
Biometrics. 2011 Sep;67(3):1047-56. doi: 10.1111/j.1541-0420.2011.01564.x. Epub 2011 Mar 1.
2
Partitioning degrees of freedom in hierarchical and other richly-parameterized models.
Technometrics. 2010 Feb 1;52(1):124-136. doi: 10.1198/TECH.2009.08161.
3
Summarizing historical information on controls in clinical trials.
Clin Trials. 2010 Feb;7(1):5-18. doi: 10.1177/1740774509356002.
5
Bayesian methods in meta-analysis and evidence synthesis.
Stat Methods Med Res. 2001 Aug;10(4):277-303. doi: 10.1177/096228020101000404.
6
Bayesian methods for cluster randomized trials with continuous responses.
Stat Med. 2001 Feb 15;20(3):435-52. doi: 10.1002/1097-0258(20010215)20:3<435::aid-sim804>3.0.co;2-e.
7
Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.
N Engl J Med. 2000 Sep 28;343(13):905-14. doi: 10.1056/NEJM200009283431302.
9
The combination of randomized and historical controls in clinical trials.
J Chronic Dis. 1976 Mar;29(3):175-88. doi: 10.1016/0021-9681(76)90044-8.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验