Royal Brompton & Harefield NHS Foundation Trust, Adult Intensive Care Unit, Sydney Street, London SW3 6NP, UK.
BMC Med. 2011 Dec 12;9:132. doi: 10.1186/1741-7015-9-132.
The validation of biomarkers has become a key goal of translational biomedical research. The purpose of this article is to discuss the role of biomarkers in the management of acute lung injury (ALI) and related research. Biomarkers should be sensitive and specific indicators of clinically important processes and should change in a relevant timeframe to affect recruitment to trials or clinical management. We do not believe that they necessarily need to reflect pathogenic processes. We critically examined current strategies used to identify biomarkers and which, owing to expedience, have been dominated by reanalysis of blood derived markers from large multicenter Phase 3 studies. Combining new and existing validated biomarkers with physiological and other data may add predictive power and facilitate the development of important aids to research and therapy.
生物标志物的验证已成为转化医学研究的一个关键目标。本文旨在讨论生物标志物在急性肺损伤（ALI）管理及相关研究中的作用。生物标志物应该是临床重要过程的敏感且特异的指标，并且应该在相关时间范围内发生变化，以影响临床试验的招募或临床管理。我们认为它们不一定需要反映发病机制。我们批判性地审查了目前用于识别生物标志物的策略，由于方便起见，这些策略主要是重新分析来自大型多中心 3 期研究的血液标志物。将新的和现有的经过验证的生物标志物与生理和其他数据相结合，可能会增加预测能力，并有助于开发重要的研究和治疗辅助工具。
