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本文引用的文献

1
Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.针对帕金森病开展侵袭性、首例人体试验:伦理考量。
Mov Disord. 2009 Oct 15;24(13):1893-901. doi: 10.1002/mds.22712.
2
Medicine. A history lesson for stem cells.医学。干细胞的历史课。
Science. 2009 May 8;324(5928):727-8. doi: 10.1126/science.1174935.
3
Why do people cooperate with medical research? Findings from three studies.为什么人们会参与医学研究?三项研究的结果
Soc Sci Med. 2009 Jun;68(12):2215-22. doi: 10.1016/j.socscimed.2009.03.034. Epub 2009 Apr 24.
4
Geron gets green light for human trial of ES cell-derived product.杰龙公司的胚胎干细胞衍生产品获人体试验许可。
Nat Biotechnol. 2009 Mar;27(3):213-4. doi: 10.1038/nbt0309-213a.
5
One in five cancer clinical trials is published: a terrible symptom--what's the diagnosis?五分之一的癌症临床试验得以发表:一个可怕的症状——诊断结果是什么?
Oncologist. 2008 Sep;13(9):923-4. doi: 10.1634/theoncologist.2008-0174. Epub 2008 Sep 15.
6
Good laboratory practice: preventing introduction of bias at the bench.良好实验室规范:防止实验台上引入偏差。
Stroke. 2009 Mar;40(3):e50-2. doi: 10.1161/STROKEAHA.108.525386. Epub 2008 Aug 14.
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Persistence of contradicted claims in the literature.文献中相互矛盾的观点持续存在。
JAMA. 2007 Dec 5;298(21):2517-26. doi: 10.1001/jama.298.21.2517.
8
Two dogmas of research ethics and the integrative approach to human-subjects research.研究伦理的两大信条与人体研究的综合方法。
J Med Philos. 2007 Mar-Apr;32(2):99-116. doi: 10.1080/03605310701255727.
9
Lost in translation: treatment trials in the SOD1 mouse and in human ALS.翻译过程中的迷失:SOD1基因小鼠和人类肌萎缩侧索硬化症的治疗试验
Neurobiol Dis. 2007 Apr;26(1):1-13. doi: 10.1016/j.nbd.2006.12.015. Epub 2007 Jan 3.
10
Comparison of treatment effects between animal experiments and clinical trials: systematic review.动物实验与临床试验治疗效果的比较:系统评价
BMJ. 2007 Jan 27;334(7586):197. doi: 10.1136/bmj.39048.407928.BE. Epub 2006 Dec 15.

研究伦理。创新疗法试验中超越准入与保护的议题。

Research ethics. Beyond access vs. protection in trials of innovative therapies.

机构信息

Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA 15213, USA.

出版信息

Science. 2010 May 14;328(5980):829-30. doi: 10.1126/science.1189369.

DOI:10.1126/science.1189369
PMID:20466907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4516403/
Abstract

Review of first-in-human trials should aim to safeguard the integrity of the scientific enterprise through a focus on pre-clinical and clinical study quality.

摘要

审查首次人体临床试验的目的应该是通过关注临床前和临床研究质量来维护科学事业的完整性。