Is Participation in Cancer Phase I Trials Really Therapeutic?
作者信息
Kimmelman Jonathan
机构信息
Jonathan Kimmelman, McGill University, Montreal, Quebec, Canada.
出版信息
J Clin Oncol. 2017 Jan 10;35(2):135-138. doi: 10.1200/JCO.2016.67.9902. Epub 2016 Sep 30.
Abstract
摘要
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1
A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib.舒尼替尼临床前研究中有效临床推断的威胁的荟萃分析。
Elife. 2015 Oct 13;4:e08351. doi: 10.7554/eLife.08351.
2
Meta-analyses of randomized controlled trials show suboptimal validity of surrogate outcomes for overall survival in advanced colorectal cancer.对随机对照试验的荟萃分析表明，晚期结直肠癌总生存替代结局的有效性欠佳。
J Clin Epidemiol. 2015 Jul;68(7):833-42. doi: 10.1016/j.jclinepi.2015.02.016. Epub 2015 Mar 6.
3
The structure of clinical translation: efficiency, information, and ethics.临床翻译的结构：效率、信息与伦理。
Hastings Cent Rep. 2015 Mar-Apr;45(2):27-39. doi: 10.1002/hast.433. Epub 2015 Jan 27.
4
American Society of Clinical Oncology policy statement update: the critical role of phase I trials in cancer research and treatment.美国临床肿瘤学会政策声明更新：I期试验在癌症研究与治疗中的关键作用
J Clin Oncol. 2015 Jan 20;33(3):278-84. doi: 10.1200/JCO.2014.58.2635. Epub 2014 Dec 15.
5
Regulation: Sell help not hope.规则：售卖帮助而非希望。
Nature. 2014 Jun 19;510(7505):336-7. doi: 10.1038/510336a.
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Clinical development success rates for investigational drugs.研究性药物的临床开发成功率。
Nat Biotechnol. 2014 Jan;32(1):40-51. doi: 10.1038/nbt.2786.
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Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials.无进展生存期作为胶质母细胞瘤总生存期的替代终点：基于91项试验的文献荟萃分析
Neuro Oncol. 2014 May;16(5):696-706. doi: 10.1093/neuonc/not236. Epub 2013 Dec 12.
8
Meta-analysis of the relationship between dose and benefit in phase I targeted agent trials.I 期靶向药物试验中剂量与疗效关系的 Meta 分析。
J Natl Cancer Inst. 2012 Dec 19;104(24):1860-6. doi: 10.1093/jnci/djs439. Epub 2012 Nov 19.
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Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early-phase oncology trials.肿瘤组织早期肿瘤学试验药效学分析的发表和报告行为。
Clin Cancer Res. 2012 Dec 1;18(23):6478-84. doi: 10.1158/1078-0432.CCR-12-1384. Epub 2012 Aug 21.
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Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment.不可切除 III 或 IV 期黑色素瘤患者接受伊匹单抗治疗的健康相关生活质量结局。
Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.
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