期刊
EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH
卷 11, 期 2, 页码 163-169出版社
EXPERT REVIEWS
DOI: 10.1586/ERP.11.12
关键词
individual change; minimal important differences; reliable change index; responder
资金
- NIH/NIA [P30-AG028748, P30-AG021684]
- NCMHD [2P20MD000182]
In recent years, the US FDA has become more critical of instruments used to measure patient-reported outcomes (PROs) in clinical trials. To facilitate decisions related to the approval of drugs, labels and promotional claims based on PROs, the FDA created the Study Endpoints and Label Development (SEALD) group. SEALD has developed a PRO guidance related to the use of PRO measures used to support drug approvals and label claims, including recommendations for establishing thresholds for meaningful change at the individual level (i.e., defining a responder). This article examines in detail the FDA-recommended methodology for defining a responder and analyzing responder-based PRO measure results. We also present other responder analysis approaches for consideration in furthering the precision and interpretation of this methodology.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据