美国对慢性阻塞性肺疾病最小临床重要差异的监管视角。

U.S. regulatory perspective on the minimal clinically important difference in chronic obstructive pulmonary disease.

作者信息

Meyer Robert J

机构信息

Office of Drug Evaluation II, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Room 13B-28, HFD-102, 5600 Fishers Lane, Rockville, Maryland 20857, USA.

出版信息

COPD. 2005 Mar;2(1):47-9. doi: 10.1081/copd-200050660.

DOI:10.1081/copd-200050660

PMID:17136961

Abstract

This paper outlines the regulatory issues surrounding the determination and use of minimally clinically important differences (MCID) in assessing measures of outcomes from treatments of chronic obstructive pulmonary disease (COPD). To place this discussion in context, it is important to understand the current state of approved therapies for COPD, as well as newer directions in therapy. This paper discusses the currently available, approved drug therapies for COPD in the United States and how they were approved. This is followed by an overview on the use of MCID for assessing outcomes in therapies for COPD, as well the more general experience with MCID from the U.S. regulatory perspective.

摘要

本文概述了在评估慢性阻塞性肺疾病（COPD）治疗效果的指标中，围绕最小临床重要差异（MCID）的确定和使用所涉及的监管问题。为了将此讨论置于背景之中，了解COPD已批准疗法的当前状况以及治疗的新方向很重要。本文讨论了美国目前可用的、已批准的COPD药物疗法以及它们是如何获批的。接下来是关于使用MCID评估COPD治疗效果的概述，以及从美国监管角度对MCID的更一般经验。