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J Clin Oncol. 2011 Nov 1;29(31):4199-204. doi: 10.1200/JCO.2011.35.5867. Epub 2011 Oct 3.
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Integrating biomarkers in clinical trials.将生物标志物纳入临床试验。
Expert Rev Mol Diagn. 2011 Mar;11(2):171-82. doi: 10.1586/erm.10.120.
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Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis.辅助化疗对可切除胃癌的获益:一项荟萃分析。
JAMA. 2010 May 5;303(17):1729-37. doi: 10.1001/jama.2010.534.
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Biomarkers and surrogate end points--the challenge of statistical validation.生物标志物和替代终点——统计验证的挑战。
Nat Rev Clin Oncol. 2010 Jun;7(6):309-17. doi: 10.1038/nrclinonc.2010.43. Epub 2010 Apr 6.
5
Toward efficient trials in colorectal cancer: the ARCAD Clinical Trials Program.迈向结直肠癌高效试验:ARCAD临床试验项目
J Clin Oncol. 2010 Feb 1;28(4):527-30. doi: 10.1200/JCO.2009.25.2544. Epub 2009 Oct 19.
6
Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials.应用荟萃分析验证癌症试验中的替代终点和生物标志物。
Cancer J. 2009 Sep-Oct;15(5):421-5. doi: 10.1097/PPO.0b013e3181b9c602.
7
Contributions of meta-analyses based on individual patient data to therapeutic progress in colorectal cancer.基于个体患者数据的荟萃分析对结直肠癌治疗进展的贡献。
Int J Clin Oncol. 2009 Apr;14(2):95-101. doi: 10.1007/s10147-009-0879-2. Epub 2009 Apr 24.
8
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).实体瘤新的疗效评价标准:修订的RECIST指南(第1.1版)
Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
9
End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group.结肠癌辅助治疗试验的终点:基于ACCENT组18项随机试验中20898例患者个体数据的观察结果与建议
J Clin Oncol. 2007 Oct 10;25(29):4569-74. doi: 10.1200/JCO.2006.10.4323. Epub 2007 Sep 17.

ARCAD 临床试验项目:更新与邀请

The ARCAD clinical trials program: an update and invitation.

机构信息

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.

出版信息

Oncologist. 2012;17(2):188-91. doi: 10.1634/theoncologist.2011-0332. Epub 2012 Feb 2.

DOI:10.1634/theoncologist.2011-0332
PMID:22302228
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3286167/
Abstract

It is widely accepted that traditional models of clinical investigation are becoming unsustainable in oncology and that trials must become more efficient in matching effective treatments to the patients most likely to benefit. In 2008, gastrointestinal oncologists from many countries began a collaboration to improve the design and conduct of clinical trials in their field, through the auspices of a French/U.S. charitable foundation, ARCAD. Whether this model of academic collaboration will be judged a success will depend on the quality of its scientific output during the next few years and whether this output, alongside that of other scientists, groups, and institutions, ultimately leads to more efficient trials and improved treatment options for patients.

摘要

人们普遍认为,传统的临床研究模式在肿瘤学领域已经难以为继,临床试验必须提高效率,将有效的治疗方法与最有可能受益的患者相匹配。2008 年,来自许多国家的胃肠肿瘤学家在美国和法国的一家慈善基金会 ARCAD 的支持下开始合作,旨在改进该领域临床试验的设计和实施。这种学术合作模式是否成功,将取决于未来几年的科学产出质量,以及这些产出,以及其他科学家、团体和机构的产出,是否最终能提高临床试验的效率,并为患者提供更多的治疗选择。