A pattern discovery framework for adverse event evaluation and inference in spontaneous reporting systems

Statistical Analysis and Data Mining

Robert Ball¹  Marianthi Markatou² 

[1] Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, Food and Drug Administration Rockville MD 20852 USA;T. J. Watson Research Center IBM Yorktown Heights NY USADepartment of Biostatistics, School of Public Health and Health Professions SUNY Buffalo Buffalo NY 14216 USA

关键词: pattern discovery;    inference;    probability models;    pharmacovigilance;    anaphylaxis;    copulas;    similarity/distance functions;   

DOI  :  10.1002/sam.11233

学科分类：社会科学、人文和艺术（综合）

来源: John Wiley & Sons, Inc.

【 摘 要 】

Abstract Safety of medical products is a major public health concern. We present a critical discussion of the currently used analytical tools for mining spontaneous reporting systems (SRS) to identify safety signals after use of medical products. We introduce a pattern discovery framework for the analysis of SRS. The terminology `pattern discovery' is borrowed from the engineering and artificial intelligence literature and signifies that the basis of the proposed framework is the medical case,.

【 授权许可】

Unknown