False alarm rates of statistical methods used in determining increased frequency of reports on adverse drug reaction
作者:
Yi Tsong,
期刊:
Journal of Biopharmaceutical Statistics
(Taylor Available online 1992)
卷期:
Volume 2,
issue 1
页码: 9-30
ISSN:1054-3406
年代: 1992
DOI:10.1080/10543409208835028
出版商: Marcel Dekker, Inc.
关键词: Adverse drug reaction;Increased frequency of reports;False alarm rate;Ratio of sales;Poisson parameter
数据来源: Taylor
摘要:
Several statistical methods have been proposed or used in the determination of an increase in frequency of reports of adverse drug reactions. Some of the methods are based on large sample approximation or equal sample sizes assumption. The actual type I error may differ significantly from the predetermined nominal level of 5% when the methods are applied to rare adverse events. Simulated false alarm rates of the methods were compared under the assumption of 10 or less expected reports in the reference period.
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