Overview of different logistical approaches to postmarketing surveillance.

The study designs used for postmarketing surveillance are those of epidemiology, but very large sample sizes are needed. Therefore, a number of specific logistical approaches have been developed. One can use spontaneous reports of adverse reactions, aggregate population based data, computerized collections of data from organized medical care programs, data collected for postmarketing surveillance on an ongoing basis, existing data collected as part of other ad hoc studies, or data collected de novo for the study being conducted. Each is described in more detail, along with its advantages and disadvantages.