Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland 20852-7234, USA.
Cancer Discov. 2013 Feb;3(2):148-57. doi: 10.1158/2159-8290.CD-12-0196. Epub 2013 Jan 8.
Researchers developing biomarkers for early detection can determine the potential for clinical benefit at early stages of development. We provide the theoretical background showing the quantitative connection between biomarker levels in cases and controls and clinically meaningful risk measures, as well as a spreadsheet for researchers to use in their own research. We provide researchers with tools to decide whether a test is useful, whether it needs technical improvement, whether it may work only in specific populations, or whether any further development is futile. The methods described here apply to any method that aims to estimate risk of disease based on biomarkers, clinical tests, genetics, environment, or behavior.
Many efforts go into futile biomarker development and premature clinical testing. In many instances, predictions for translational success or failure can be made early, simply based on critical analysis of case–control data. Our article presents well-established theory in a form that can be appreciated by biomarker researchers. Furthermore, we provide an interactive spreadsheet that links biomarker performance with specific disease characteristics to evaluate the promise of biomarker candidates at an early stage.
目的：开发用于早期检测的生物标志物的研究人员可以在开发的早期阶段确定其具有临床获益的潜力。我们提供了理论背景，显示了病例和对照组中生物标志物水平与具有临床意义的风险指标之间的定量关系，以及供研究人员在自己的研究中使用的电子表格。我们为研究人员提供了工具，以确定测试是否有用，是否需要技术改进，是否仅在特定人群中有效，或者是否进一步开发是徒劳的。这里描述的方法适用于任何旨在基于生物标志物、临床测试、遗传学、环境或行为来估计疾病风险的方法。
意义：许多用于生物标志物开发和过早临床测试的努力都是徒劳的。在许多情况下，基于对病例对照数据的严格分析，可以尽早对转化成功或失败的预测做出判断。我们的文章以生物标志物研究人员能够理解的形式呈现了成熟的理论。此外，我们提供了一个交互式电子表格，将生物标志物性能与特定疾病特征联系起来，以在早期阶段评估生物标志物候选物的前景。
