Introducing PV

Before a drug is launched for use, it is tested in small populations under controlled settings, which prevents us from understanding how the drug would behave in the long term on large groups of people. PV refers to the activities and science related to the detection, assessment, and prevention of adverse effects related to medicines. It is designed to improve patient safety and confidence around the use of the drug. During clinical research, PV is conducted by monitoring the patients closely in controlled environments. Post-launch, PV is carried out via observational studies and post-market surveillance (PMS). While the data collected during a clinical trial is better in quality, it is quite limited. Hence, the post-market PV attempts to draw conclusions from a wider real-world dataset in uncontrolled settings.

The central element of post-market PV revolves around the concept of monitoring drug usage in the real world for extended periods of time. During the monitoring...