抄録
The decision making process by patients of whether or not to participate in clinicaltrials occurs in relation to the balance of profits obtained from clinical trials and thedisadvantage (especially, health damage) experienced in clinical trials, and the informationabout a critical adverse event is an important factor in the decision making process.
Among all report cases (1, 907 cases) provided to our hospital, 1, 014 cases (53%) were known adverse reactions and 844 cases (44%) were newly detected, The invesigators (physicians) judged the causal relationship between the investigationaldrug and adverse events observed, as follows ; “definite” 228 cases (12%), “probable” 555 cases (29%), “unlikely” 118 cases (6%), and “unknown” 907 cases (48%).Because about one half of all events make up “unknown” events, the burden andresponsibility of the medical institutions which undertake clinical trials to evaluate theclinical importance of reported events are very large.
Many of the events are observed in the drugs which are available commercially inforeign countries at present, and the burden of information management is great for theinstitutions. Another new problem is the difference in the interpretation of informationgiven in English, such as CIOMS report style and Med Watch report style, which maycause some confusion.
It is possible to enhance the accuracy of judging a causal relationship by standardizationof the information item and establishing the collection system . The transmission ofinformation using electronic media can increase the efficiency of data management inboth the medical institutions and the clinical trials subjects.
