Hodgson Darren R, Whittaker Robin D, Herath Athula, Amakye Dereck, Clack Glen
Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Mol Oncol. 2009 Feb;3(1):24-32. doi: 10.1016/j.molonc.2008.12.002. Epub 2008 Dec 11.
Biomarker measurements have become an essential component of oncology drug development, particularly so in this era of targeted therapies. Such measurements ensure that clinical studies are testing our biological hypotheses and can help make the difficult decisions required to choose which drugs to stop developing or de-prioritise. For those drugs taken forward, biomarker measurements may also help choose the appropriate dose, schedule and patient population. In this review we discuss the intrinsic properties of biological sample based efficacy measurements and how these relate to their implementation in oncology drug development by way of points to consider and examples.
生物标志物检测已成为肿瘤药物研发的重要组成部分，在这个靶向治疗的时代尤其如此。此类检测可确保临床研究对我们的生物学假设进行验证，并有助于做出艰难决策，以决定停止研发哪些药物或降低其优先级。对于推进研发的药物，生物标志物检测还可能有助于选择合适的剂量、给药方案和患者群体。在本综述中，我们将讨论基于生物样本的疗效检测的内在特性，以及如何通过要点和实例将这些特性应用于肿瘤药物研发。
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