Med Devices PMS PMCF when AE Reporting is low
Sample size estimation is an important step before undertaking any clinical study. However, the entire process depends upon the number of patients to be included for the proposed study. The purpose of this paper is to provide a reference table containing sample size required for a post marketing clinical trial when there is no background incidence of adverse events in the general population. The table provides sample size for various options such as the expected incidence rate of adverse reactions and the number of occurrence of a particular adverse reaction along with various statistical powers.