Safety Reporting in Randomized Clinical Trials A Need for Improvement

被引：0
作者：
Yazici, Yusuf [1 ,2 ]
机构：
[1] New York Univ, Sch Med, Med, New York, NY USA
[2] NYU Hosp, NYU Langone Med Ctr, Dept Med, Div Rheumatol, New York, NY USA
来源：
BULLETIN OF THE HOSPITAL FOR JOINT DISEASES | 2009年 / 67卷 / 02期
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D O I：
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中图分类号：
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];
学科分类号：
摘要：
The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs.
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页码：209 / 210
页数：2
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