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Statistical aspects of monitoring for dangers in drug therapy.

Because a therapeutic drug has a complicated life history and because certain beneficial drugs have produced unexpected harmful or dangerous effects it is important to understand their medical pharmacological toxicological and administrative connections. An evolving pattern of detection is presented in which monitoring depends upon submission of individual reports by medical practitioners to a central register voluntarily and spontaneously. The basic statistical problem appears to be one of collecting and evaluating informatin that may constitute suspicion calling for intensive and objectively planned research. The aim of a spontaneous monitoring system is reduction of the threshold at which a physician will take action. The computer allows for collection storage tabulation search and scrutiny of information. It is the duty of statisticians and medical workers to protect patients from misfortunes associated with therapeutic drugs.