Various methods are used throughout the life cycle of the product (from all phases of clinical trials and post-marketing) to evaluate new information that comes in routinely. This is called signal detection. Signal detection is one of the most important objectives of pharmacovigilance. The whole process of risk/benefit evaluation depends on effective detection of signals. Methods for signal detection include observations by clinicians and patients, case reports in the literature, assessment of individual case reports or clusters of reports that are received from healthcare professionals, patients and consumers etc, data from formal studies, e.g. clinical trials, epidemiological studies like cohort studies and case control studies.
The detection of signals require clinical assessment assisted by epidemiological and statistical analysis. Information technology tools also help in the generation of signals and enhancing its effectiveness. Automated signal generation is used by many MNCs, where reported safety profile of a particular product is compared with other products in the database using simple statistical methods like proportional reporting rates (PRR). Apart from PRR, which is very popular, there are other statistical tools used for signal detection that are used like incidence rates, frequency of adverse events and trend analysis.
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