1 Respiratory Therapy Area Unit, GlaxoSmithKline Research and Development, King of Prussia, Pennsylvania.
2 Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Nebraska Medical Center, Omaha, Nebraska.
Am J Respir Crit Care Med. 2016 Mar 15;193(6):607-13. doi: 10.1164/rccm.201509-1722PP.
The COPD Foundation Biomarker Qualification Consortium (CBQC) is a unique public-private partnership established in 2010 between the COPD Foundation, the pharmaceutical industry, and academic chronic obstructive pulmonary disease (COPD) experts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA). This was a direct response to the 2009 publication of a guidance on qualification of drug development tools by the FDA. Although data were believed to be available from publicly funded and industry-funded studies that could support qualification of several tools, the necessary data resided in disparate databases. The initial intent of the CBQC was to integrate these data and submit a dossier for the qualification. This led to the FDA qualification of plasma fibrinogen as a prognostic or enrichment biomarker for all-cause mortality and COPD exacerbations in July 2015. It is the first biomarker drug development tool qualified for use in COPD under the FDA's drug development tool qualification program. This perspective summarizes the FDA's qualification process, the formation of the CBQC, and the effort that led to a successful outcome for plasma fibrinogen and discusses implications for future biomarker qualification efforts.
COPD 基金会生物标志物资格认证联盟（CBQC）是一个独特的公私合作伙伴关系，于 2010 年由 COPD 基金会、制药行业以及学术性慢性阻塞性肺疾病（COPD）专家与美国 NHLBI 和食品药品监督管理局（FDA）的顾问共同建立。这是对 2009 年 FDA 发布的关于药物开发工具资格认证指南的直接回应。尽管人们认为可以从公共资助和行业资助的研究中获得支持几种工具资格认证的可用数据，但必要的数据却存在于不同的数据库中。CBQC 的最初意图是整合这些数据并提交一份资格认证文件。这导致了 2015 年 7 月 FDA 将血浆纤维蛋白原资格认证为全因死亡率和 COPD 恶化的预后或富集生物标志物。这是 FDA 药物开发工具资格认证计划下第一个用于 COPD 的生物标志物药物开发工具。本观点总结了 FDA 的资格认证流程、CBQC 的形成以及导致血浆纤维蛋白原成功获得认证的努力，并讨论了对未来生物标志物资格认证工作的影响。
