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DEFINING, MONITORING AND COMBINING SAFETY INFORMATION IN CLINICAL TRIALS
Author(s) -
Enas Gregory G.,
Goldstein David J.
Publication year - 1995
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780140930
Subject(s) - flexibility (engineering) , clinical trial , computer science , data collection , safety monitoring , risk analysis (engineering) , patient safety , data science , medicine , health care , statistics , mathematics , microbiology and biotechnology , pathology , economics , biology , economic growth
Assessment of clinical trial safety data for industry, regulatory agencies, medical practitioners and patients requires definition and measurement, monitoring, and overall analysis. Prospective ‘safety’ definitions and reliable measurement tools reduce inefficient data collection and improve the validity of resulting analyses. Statistical tools can help investigators monitor safety data from controlled clinical trials and help improve post‐marketing surveillance. Also, when evaluating overall safety, one needs to assess all available information by combining information from many trials and other sources. Planning for this combined assessment, incorporating flexibility to assess unanticipated yet important nuances in individual trials, may be more important than the actual statistical analysis method used. A keen awareness of the future needs of consumers of this infomation is quite important. Some current proposals to combine safety information will be discussed.