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Interpreting results from biomarker-guided clinical trials: avoiding "negative" or "failed" terminology.

作者信息

Noor Nurulamin M, Zheng Haiyan, Robertson David S, Savage Joshua, Yap Christina, Jorgensen Andrea L, Wason James M S

机构信息

Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

Department of Medicine, School of Clinical Medicine, University of Cambridge, Cambridge, UK.

出版信息

BMC Med. 2025 May 28;23(1):314. doi: 10.1186/s12916-025-04035-9.

DOI:10.1186/s12916-025-04035-9
PMID:40437496
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12121256/
Abstract
摘要

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本文引用的文献

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A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn's disease (PROFILE): a multicentre, open-label randomised controlled trial.一种生物标志物分层比较新诊断克罗恩病患者自上而下与加速阶梯治疗策略的效果（PROFILE）：一项多中心、开放标签随机对照试验。
Lancet Gastroenterol Hepatol. 2024 May;9(5):415-427. doi: 10.1016/S2468-1253(24)00034-7. Epub 2024 Feb 22.
2
Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study.开放性、多中心、随机化、基于生物标志物的晚期胃癌二线治疗伞式试验：K-伞式胃癌研究。
J Clin Oncol. 2024 Jan 20;42(3):348-357. doi: 10.1200/JCO.23.00971. Epub 2023 Oct 26.
3
How to Use and Interpret the Results of a Platform Trial: Users' Guide to the Medical Literature.如何使用和解释平台试验的结果：医学文献用户指南。
JAMA. 2022 Jan 4;327(1):67-74. doi: 10.1001/jama.2021.22507.
4
The Magic of Randomization versus the Myth of Real-World Evidence.随机化的魔力与真实世界证据的神话
N Engl J Med. 2020 Feb 13;382(7):674-678. doi: 10.1056/NEJMsb1901642.
5
Biomarker-guided trials: Challenges in practice.生物标志物引导的试验：实践中的挑战。
Contemp Clin Trials Commun. 2019 Nov 16;16:100493. doi: 10.1016/j.conctc.2019.100493. eCollection 2019 Dec.
6
Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.生物标志物引导的II期和III期非适应性试验设计：方法学综述
J Pers Med. 2017 Jan 25;7(1):1. doi: 10.3390/jpm7010001.
7
Early-Phase Studies of Biomarkers: What Target Sensitivity and Specificity Values Might Confer Clinical Utility?生物标志物的早期研究：何种目标敏感性和特异性值可能具有临床实用性？
Clin Chem. 2016 May;62(5):737-42. doi: 10.1373/clinchem.2015.252163. Epub 2016 Mar 21.
8
The Scientific Impact of Positive and Negative Phase 3 Cancer Clinical Trials.阳性和阴性 3 期癌症临床试验的科学影响。
JAMA Oncol. 2016 Jul 1;2(7):875-81. doi: 10.1001/jamaoncol.2015.6487.
9
Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.二、三期生物标志物引导的适应性试验设计：方法学综述
PLoS One. 2016 Feb 24;11(2):e0149803. doi: 10.1371/journal.pone.0149803. eCollection 2016.
10
Biomarker enrichment strategies: matching trial design to biomarker credentials.生物标志物富集策略：将试验设计与生物标志物特征相匹配。
Nat Rev Clin Oncol. 2014 Feb;11(2):81-90. doi: 10.1038/nrclinonc.2013.218. Epub 2013 Nov 26.