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Updated: Jul 16, 2025

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
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跨部门调查协议质量随时间的演变:指数美国REMS知识调查协议 (2007-2020) 的案例系列 (2007-2020)

Gita A Toyserkani1, Samuel B Ewusie2,3, Philip Turk4

  • 1Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 1106, Silver Spring, MD, 20993, USA. Gita.Toyserkani@fda.hhs.gov.

Drug safety
|September 11, 2023
PubMed
概括

随着时间的推移,FDA要求的风险评估和缓解策略 (REMS) 知识调查的科学严谨性得到了改善,统计分析计划取得了显著的收益. 然而,研究设计要素需要进一步改进,以进行全面的REMS有效性评估.

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