Post-marketing Surveillance Study, why is it important?

When manufacturing a new medical product, such as new drugs or therapies, pharmaceutical companies go through clinical trials to ensure that products are safe, effective and efficacious. Although these trials are heavily regulated processes, not all side effects of a drug can’t be anticipated making essential to monitor, identify and assess adverse events that did not appear during the drug approval process. This post-approval vigilant process is called Post-marketing Surveillance (PMS) and can be conducted by various types of organizations and agencies,  including pharmaceutical manufacturers, universities, government agencies, private companies, and consumer advocacy groups.

Post-marketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription-event monitoring, electronic health records, patient registries, and record linkage between health databases. The data may be captured electronically at its source (called e-source), or in paper form and later transcribed into an Electronic Data Capture (EDC) system. These data are reviewed to highlight potential safety concerns in a process known as data mining.

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Source: WHO and U.S. Food & Drug Administration