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Why do cancer drugs get such an easy ride?

作者信息

Light Donald W, Lexchin Joel

机构信息

School of Osteopathic Medicine, Rowan University, Cherry Hill, NJ 08002, USA

School of Health Policy and Management, York University, Toronto, ON, Canada.

出版信息

BMJ. 2015 Apr 23;350:h2068. doi: 10.1136/bmj.h2068.

DOI:10.1136/bmj.h2068
PMID:25908437
Abstract
摘要

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Why do cancer drugs get such an easy ride?为什么抗癌药物的审批如此轻松？
BMJ. 2015 Apr 23;350:h2068. doi: 10.1136/bmj.h2068.
2
[The decisive steps cost billions. Extensive studies provide answers for many questions].决定性的步骤耗资数十亿美元。广泛的研究为许多问题提供了答案。
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Quality assurance in phase II and III studies.II期和III期研究中的质量保证。
Qual Assur. 1993 Dec;2(4):353-8.
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Indian Supreme Court halts approval of new clinical trials until regulatory framework is set up.印度最高法院暂停新临床试验的批准，直至建立监管框架。
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Approaches to the development and marketing approval of drugs that prevent cancer.预防癌症药物的研发及上市批准途径。
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Company stock prices before and after public announcements related to oncology drugs.与肿瘤药物相关的公司公告前后的股价。
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Accelerated approval seen as triumph and roadblock for cancer drugs.加速批准被视为抗癌药物的胜利与障碍。
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Oncology's first Phase 0 trial.肿瘤学的首个0期试验。
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Medicines management. NICE (National Institute for Clinical Excellence) but not easy.药品管理。英国国家临床优化研究所（NICE）负责，但并不容易。
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