Gliske Stephen V, Stacey William C
Department of Neurosurgery, University of Nebraska Medical Center, Omaha, NE, USA.
Department of Neurology, University of Michigan, Ann Arbor, MI, USA.
Epilepsy Curr. 2023 Mar 30;23(3):175-178. doi: 10.1177/15357597231159714. eCollection 2023 May-Jun.
The search for valid biomarkers to aid in epilepsy diagnosis and management is a major goal of the Epilepsy Research Benchmarks. Many papers and grants answer this call by searching for new biomarkers from a wide range of disciplines. However, the academic use of the word "biomarker" is often imprecise. Without proper definition, such work is not well-prepared to progress to the next step of translating these biomarkers into clinical use. In 2016, the Food and Drug Administration and National Institutes of Health collaborated to develop the BEST (Biomarkers, EndpointS, and other Tools) Resource as a guide to adopt formal definitions that aid in pushing successful biomarkers toward regulatory approval. Using the vignette of high-frequency oscillations, which have been proposed as a potential biomarker of several potential aspects of epilepsy, we demonstrate how improper use of the term "biomarker," and lack of a clear context of use, can lead to confusion and difficulty obtaining regulatory approval. Similar conditions are likely in many areas of biomarker research. This Resource should be adopted by all researchers developing epilepsy biomarkers. Adopting the BEST guidelines will improve reproducibility, guide research objectives toward translation, and better target the Epilepsy Benchmarks.
寻找有效的生物标志物以辅助癫痫的诊断和管理是癫痫研究基准的一个主要目标。许多论文和研究资助通过从广泛学科中寻找新的生物标志物来响应这一呼吁。然而，“生物标志物”一词在学术上的使用往往并不精确。如果没有恰当的定义，此类工作就没有做好推进到将这些生物标志物转化为临床应用的下一步的准备。2016年，美国食品药品监督管理局和美国国立卫生研究院合作开发了BEST（生物标志物、终点指标及其他工具）资源，作为采用有助于推动成功的生物标志物获得监管批准的正式定义的指南。通过以高频振荡为例（高频振荡已被提议作为癫痫几个潜在方面的一种潜在生物标志物），我们展示了“生物标志物”一词的不当使用以及缺乏明确的使用背景是如何导致混淆以及难以获得监管批准的。在生物标志物研究的许多领域可能都存在类似情况。所有研发癫痫生物标志物的研究人员都应采用这一资源。采用BEST指南将提高可重复性，引导研究目标朝着转化方向发展，并更好地瞄准癫痫基准。
