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本文引用的文献

1
How large a training set is needed to develop a classifier for microarray data?开发一个用于微阵列数据的分类器需要多大的训练集?
Clin Cancer Res. 2008 Jan 1;14(1):108-14. doi: 10.1158/1078-0432.CCR-07-0443.
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On the dynamics of breast tumor development in women carrying germline BRCA1 and BRCA2 mutations.
Int J Cancer. 2008 Apr 15;122(8):1916-7. doi: 10.1002/ijc.23323.
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Finding clinical meaning in cancer data.
J Natl Cancer Inst. 2007 Dec 19;99(24):1832-5. doi: 10.1093/jnci/djm283. Epub 2007 Dec 11.
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Microarrays: retracing steps.微阵列:追溯步骤。
Nat Med. 2007 Nov;13(11):1276-7; author reply 1277-8. doi: 10.1038/nm1107-1276b.
5
Translational investigators: life sciences' application engineers.转化医学研究者:生命科学领域的应用工程师。
Nat Biotechnol. 2007 Jul;25(7):817-8. doi: 10.1038/nbt0707-817.
6
Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen.他莫昔芬治疗的早期乳腺癌患者中21基因复发评分预后检测的开发及临床应用
Oncologist. 2007 Jun;12(6):631-5. doi: 10.1634/theoncologist.12-6-631.
7
Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.生物标志物适应性阈值设计:一种评估具有可能由生物标志物定义的亚组效应的治疗方法。
J Natl Cancer Inst. 2007 Jul 4;99(13):1036-43. doi: 10.1093/jnci/djm022. Epub 2007 Jun 27.
8
A method for testing a prespecified subgroup in clinical trials.一种在临床试验中检验预先指定亚组的方法。
Stat Med. 2007 Aug 30;26(19):3535-49. doi: 10.1002/sim.2825.
9
Critical review of published microarray studies for cancer outcome and guidelines on statistical analysis and reporting.已发表的癌症预后微阵列研究的批判性综述以及统计分析与报告指南。
J Natl Cancer Inst. 2007 Jan 17;99(2):147-57. doi: 10.1093/jnci/djk018.
10
Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer.70基因预后特征对淋巴结阴性乳腺癌女性患者的验证及临床应用价值
J Natl Cancer Inst. 2006 Sep 6;98(17):1183-92. doi: 10.1093/jnci/djj329.

翻译中的困境:将实验室观察结果转化为临床应用中的问题与陷阱。

Lost in translation: problems and pitfalls in translating laboratory observations to clinical utility.

作者信息

Simon Richard

机构信息

National Cancer Institute, Division of Cancer Treatment and Diagnosis, Bethesda, MD 20892, USA.

出版信息

Eur J Cancer. 2008 Dec;44(18):2707-13. doi: 10.1016/j.ejca.2008.09.009. Epub 2008 Nov 1.

DOI:10.1016/j.ejca.2008.09.009
PMID:18977655
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2646591/
Abstract

Developments in whole genome biotechnology have dramatically increased the opportunities for developing more effective therapeutics and for targeting them to patients who require them and who can benefit from them. This can have profound benefits for patients and for the economics of health care. There are, however, many obstacles to overcome in achieving this revolution. The effectiveness of translational research in oncology is seriously limited by many factors, both structural and scientific. Some of the obstacles involve the failure of biomedical organisations to develop and fund new models of inter-disciplinary collaboration needed to attract and support the best and brightest quantitative scientists to predictive medicine. Many of the challenges are scientific, requiring paradigm changes in the way drugs are developed and in the way clinical trials are designed and analysed. Some of these issues are addressed here, specifically in the context of developing molecular diagnostics in a manner that moves retrospective correlative science to prospective predictive medicine.

摘要

全基因组生物技术的发展极大地增加了开发更有效治疗方法的机会,并使这些治疗方法能够针对需要它们且能从中受益的患者。这对患者和医疗保健经济都可能带来深远益处。然而,要实现这一变革还有许多障碍需要克服。肿瘤学转化研究的有效性受到许多结构和科学因素的严重限制。一些障碍包括生物医学组织未能开发和资助新型跨学科合作模式,而这种模式是吸引和支持最优秀、最聪明的定量科学家投身预测医学所必需的。许多挑战是科学性的,需要在药物研发方式以及临床试验设计和分析方式上进行范式转变。本文将探讨其中一些问题,特别是在以一种将回顾性关联科学转变为前瞻性预测医学的方式开发分子诊断技术的背景下。