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肺癌临床试验方法学

Methodology of clinical trials in lung cancer.

作者信息

Menis Jessica, Besse Benjamin, Lacombe Denis

机构信息

EORTC Headquarters, Brussels, Belgium.

Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.

出版信息

Chin Clin Oncol. 2015 Dec;4(4):44. doi: 10.3978/j.issn.2304-3865.2015.11.03.

Abstract

The identification of new targets in cancer biology has changed the traditional approach to cancer diagnosis and treatment and therefore also to drug development. The classical 'one size fits all' approach needed to be modified into a tailored approach that took into account the patient-to-patient variation. Innovative trials are warranted, based on the integration of new types of design and integrating the knowledge coming from new disciplines like bioinformatics, biostatistics, epidemiology and health economics. Several initiatives have started at national levels but also in large pan-European academic organizations [like the European Organization for Research and Treatment of Cancer (EORTC)] in the scope of generating a harmonized healthcare landscape across Europe.

摘要

癌症生物学中新靶点的识别改变了癌症诊断和治疗的传统方法,因此也改变了药物研发的传统方法。经典的“一刀切”方法需要转变为一种量身定制的方法,该方法要考虑到患者之间的差异。基于新型设计的整合以及整合来自生物信息学、生物统计学、流行病学和卫生经济学等新学科的知识,开展创新试验是很有必要的。在国家层面以及大型泛欧洲学术组织[如欧洲癌症研究与治疗组织(EORTC)]中已经启动了多项举措,旨在打造全欧洲协调统一的医疗格局。

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