Qualification of imaging biomarkers for oncology drug development
Qualification of imaging biomarkers for oncology drug development
复制标题
DOI：
10.1016/j.ejca.2011.11.037
复制
发表时间：
2012-03-01
影响因子：
8.4
通讯作者：
Pylkkanen, Liisa
中科院分区：
文献类型：
--
作者：
Waterton, John C.;Pylkkanen, Liisa
尽管许多成像生物标志物已被描述用于癌症研究，但很少有足够强大、可靠且特征良好的生物标志物可以用作临床癌症研究的常规工具。特别是，表明研究疗法减少肿瘤细胞增殖或诱导坏死或凋亡细胞死亡的生物标志物通常不用于支持药物开发决策，尽管这种药效效应是许多类别研究药物的共同目标。此外，我们缺乏转移倾向的合格生物标志物。成像生物标志物的鉴定和技术验证提出了验证生物样本生物标志物时并不总是遇到的独特挑战。这些包括采集和分析的标准化、影像病理学相关性、横截面临床生物标志物相关性以及与结果的相关性。此类工作非常适合竞争前研究和公私合作伙伴关系，这一点已在创新药物倡议 (IMI) 中得到认可，该倡议是欧盟与欧洲制药工业和协会联合会之间的一项联合项目，已启动了药物安全、药物功效、知识管理和培训领域的项目。 (C) 2011 Elsevier Ltd. 保留所有权利。
Although many imaging biomarkers have been described for cancer research, few are sufficiently robust, reliable and well-characterised to be used as routine tools in clinical cancer research. In particular, biomarkers which show that investigational therapies have reduced tumour cell proliferation, or induced necrotic or apoptotic cell death are not commonly used to support decision-making in drug development, even though such pharmacodynamic effects are common goals of many classes of investigational drugs. Moreover we lack well-qualified biomarkers of propensity to metastasise. The qualification and technical validation of imaging biomarkers poses unique challenges not always encountered when validating biospecimen biomarkers. These include standardisation of acquisition and analysis, imaging-pathology correlation, cross-sectional clinical-biomarker correlations and correlation with outcome. Such work is ideally suited to precompetitive research and public-private partnerships, and this has been recognised within the Innovative Medicines Initiative (IMI), a Joint Undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, which has initiated projects in the areas of drug safety, drug efficacy, knowledge management and training. (C) 2011 Elsevier Ltd. All rights reserved.