Chowdhury Ferdousi, Williams Anthony
CRUK Clinical Centre, Somers Cancer Research Building, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.
Bioanalysis. 2009 May;1(2):285-91. doi: 10.4155/bio.09.51.
The current decade has seen an evolution in biomarker research, with a breakthrough from traditional single analyte studies to simultaneous multiple analyte technologies, aided by the progressive development of research tools and the discovery of many novel biomarkers. It is foreseeable that the application of such technologies will have an integral role in clinical studies for establishing biomarker profiles of disease status and prognosis. However, the transfer of such complex procedures to a regulated environment presents many obstacles. Here, we discuss some of these applied technologies and the validation approaches we have taken as an academic unit to prove their suitability and appropriateness for clinical application. We discuss the advantages and limitations for such end point assays in early Phase clinical trials.
在当前这十年中，生物标志物研究不断发展，借助研究工具的不断进步和众多新型生物标志物的发现，实现了从传统单一分析物研究到同步多分析物技术的突破。可以预见，此类技术的应用将在建立疾病状态和预后生物标志物谱的临床研究中发挥不可或缺的作用。然而，将此类复杂程序转移到规范环境中存在诸多障碍。在此，我们讨论其中一些应用技术以及作为一个学术单位为证明其适用于临床应用而采取的验证方法。我们还讨论了此类终点检测在早期临床试验中的优缺点。
