Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J
Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2015 Jul;98(1):34-46. doi: 10.1002/cpt.136. Epub 2015 Jun 6.
The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration.
为实现各种药物研发目的而进行生物标志物的发现、开发和使用，是极具吸引力且很有必要的领域。在药物审批过程中提交生物标志物数据，可使生物标志物被认可用于药物研发。另一条使生物标志物获得认可的新兴途径，是通过美国食品药品监督管理局药品评价和研究中心（CDER）制定的生物标志物资格认定计划。需要制定证据标准，以便针对其预期用途来开发和评估各类生物标志物，包括学术界、产业界、政府和财团在内的多个利益相关方必须共同努力，以协助提供这一证据。本文描述了在药物研发中可能有用的各类生物标志物，以及资格认定所需考虑的重要证据因素。文中还提出了一条协调各方力量以识别和探索所需生物标志物的前进道路，以供参考。
