Surveillance system for adverse events during drug development studies

摘要

A method for clinical surveillance of a treatment group and an other group involves defining an adverse event, possible a serious adverse event, noting each occurrence of the adverse events, and, starting at zero, calculating a cumulative sum of the adverse events by updating the cumulative sum each time a further adverse event is reported and, when the adverse event is in the treatment group, adding 1 to the cumulative sum, and, when the adverse event is in the other group, adding 0 to the cumulative sum. This invention also involves subtracting a chosen quantity K from the cumulative sum, comparing the cumulative sum to a predetermined alarm limit, determining when the cumulative sum reaches at least the predetermined alarm limit, and indicating the predetermined alarm limit has been reached.