数据和安全监测委员会监测早期疗效临床试验。
Data and Safety Monitoring Board Monitoring of Clinical Trials for Early Efficacy.
机构信息
National Institute of Allergy and Infectious Diseases, Bethesda, MD.
出版信息
NEJM Evid. 2022 Mar;1(3):EVIDctw2100025. doi: 10.1056/EVIDctw2100025. Epub 2022 Feb 22.
PMID:38319232
Abstract
DSMB Monitoring of Clinical Trials for Early EfficacyIn this article in the DSMB mini-series, Dodd and Proschan review the clinical, ethical, and statistical issues that confront a DSMB when trial data suggest that the treatment under test is highly efficacious. Examples of such trials are reviewed.
摘要
临床试验早期疗效的 DSMB 监测 在这篇 DSMB 迷你系列文章中，Dodd 和 Proschan 综述了当试验数据表明受试治疗方法非常有效时，DSMB 面临的临床、伦理和统计问题。还回顾了此类试验的一些示例。
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