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本文引用的文献

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Incremental advance or seismic shift? The need to raise the bar of efficacy for drug approval.渐进式进步还是重大变革?提高药物审批效力标准的必要性。
J Clin Oncol. 2009 Dec 10;27(35):5868-73. doi: 10.1200/JCO.2009.22.4162. Epub 2009 Oct 13.
2
Treatment strategies for pediatric acute myeloid leukemia.儿童急性髓系白血病的治疗策略
Expert Opin Pharmacother. 2009 Jan;10(1):57-79. doi: 10.1517/14656560802627929.
3
Clinical cancer advances 2008: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.《2008年临床癌症进展:癌症治疗、预防及筛查的重大研究进展——美国临床肿瘤学会报告》
J Clin Oncol. 2009 Feb 10;27(5):812-26. doi: 10.1200/JCO.2008.21.2134. Epub 2008 Dec 22.
4
Time for reform in the drug-development process.药物研发过程需要改革了。
Lancet Oncol. 2008 Dec;9(12):1125-6. doi: 10.1016/s1470-2045(08)70297-3.
5
New drugs for the treatment of lymphoma.治疗淋巴瘤的新药。
Hematol Oncol Clin North Am. 2008 Oct;22(5):1007-35, x. doi: 10.1016/j.hoc.2008.07.006.
6
Role of the microenvironment in tumor growth and in refractoriness/resistance to anti-angiogenic therapies.微环境在肿瘤生长以及对抗血管生成疗法的难治性/抗性中的作用。
Drug Resist Updat. 2008 Dec;11(6):219-30. doi: 10.1016/j.drup.2008.09.001. Epub 2008 Oct 23.
7
Targeted therapies for pancreatic cancer.胰腺癌的靶向治疗
Br Med Bull. 2008;87:97-130. doi: 10.1093/bmb/ldn027. Epub 2008 Aug 27.
8
The role of inhibitors of the epidermal growth factor in management of head and neck cancer.表皮生长因子抑制剂在头颈部癌治疗中的作用。
J Natl Compr Canc Netw. 2008 Aug;6(7):696-706. doi: 10.6004/jnccn.2008.0052.
9
Current adjuvant and targeted therapies for pancreatic adenocarcinoma.胰腺癌当前的辅助治疗和靶向治疗
Curr Med Chem. 2008;15(17):1674-83. doi: 10.2174/092986708784872348.
10
Multi-arm clinical trials of new agents: some design considerations.新型药物的多臂临床试验:一些设计考量
Clin Cancer Res. 2008 Jul 15;14(14):4368-71. doi: 10.1158/1078-0432.CCR-08-0325.

临床癌症研究的结构改革五步骤。

Five steps for structural reform in clinical cancer research.

出版信息

Am J Public Health. 2010 Apr;100(4):596-603. doi: 10.2105/AJPH.2009.168633. Epub 2010 Feb 18.

DOI:10.2105/AJPH.2009.168633
PMID:20167889
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2836352/
Abstract

Despite advances in the prevention and early detection of cancer and the treatment of some malignancies, clinical research has not yet delivered treatment benefits of the magnitude anticipated after the launch of imatinib, which established highly effective new treatment standards. The primary impediments to progress are scientific, but the efficiency of research is also affected by structural deficiencies relating to where and by whom it is conducted, as well as how it is organized and regulated. To optimize the research environment and maximize the benefits of improved funding, adjustments in the roles of government, industry, the academic community, national research bodies, and regulatory authorities are needed. A patchwork of reforms that are enabling in character and build on existing expertise can deliver substantial progress without the need for radical intervention.

摘要

尽管在癌症的预防、早期发现和某些恶性肿瘤的治疗方面取得了进展,但临床研究仍未像伊马替尼(imatinib)推出后所预期的那样带来治疗效益,伊马替尼确立了高度有效的新治疗标准。阻碍进展的主要原因是科学方面的,但研究的效率也受到与研究的地点和执行者以及研究的组织和管理方式有关的结构性缺陷的影响。为了优化研究环境并最大限度地提高改善资金的效益,需要调整政府、工业界、学术界、国家研究机构和监管机构的作用。一系列具有启发性且以现有专业知识为基础的改革可以在不需要激进干预的情况下取得重大进展。