AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Eur J Cancer. 2012 Mar;48(4):409-15. doi: 10.1016/j.ejca.2011.11.037. Epub 2012 Jan 5.
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.
虽然已经有许多影像学生物标志物被描述用于癌症研究，但很少有足够强大、可靠和特征明确的生物标志物可以作为癌症临床研究的常规工具。特别是，用于支持药物开发决策的生物标志物，这些标志物显示出研究性治疗方法已降低肿瘤细胞增殖，或诱导坏死或凋亡细胞死亡的生物标志物并不常用，尽管这种药效学效应是许多类研究性药物的常见目标。此外，我们缺乏转移性倾向的有资格的生物标志物。成像生物标志物的资格和技术验证带来了独特的挑战，这些挑战在验证生物标本生物标志物时并不总是遇到。这些包括采集和分析的标准化、影像学-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。这类工作非常适合于竞争前研究和公私合作伙伴关系，这在创新药物倡议（IMI）中得到了认可，该倡议是欧盟与欧洲制药工业和协会联合会之间的一个联合机构，已经在药物安全、药物疗效、知识管理和培训领域启动了项目。
