Mnagement of Information about Advarse Events in Clinical Trials

概要

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Information about safety greatly affects the decision by patients as to whether or not they will participate in clinical trails. Therefore, it is important to keep all participants fully informed. However, it is very difficult to manage information about adverse events that are reported during clinical trials, mainly because the amount of information is large and the casual relationship with investigational drug administration is often unclear. We sought to develop a method to effectively evaluate the clinical significance of reported adverse events and to also efficiently manage information. The adverse events reported to our institution by trial sponsors during the period between September 1999, and December 2001 were classified based on an evaluation of three factors ; the degree or health hazard, the character (geographical location, previously known or new effect, clinical trial phase or post marketing phase), and causal relationship with the investigational drug. Based on the results of this analysis and a questionnaire survey of trial sponsors, we recommended that adverse events should be routinely categorized into three classes in the manner described above, and the data regarding each event should be Gathered in a standardized format, and electronic media should be used to transmit the data.
2003-04-10