Real-world settings (RWS) refer to the use of data collected from real-life clinical practice, outside of controlled clinical trials. This data helps to understand how a drug performs in a broader patient population and can inform post-market surveillance and ongoing safety monitoring. By leveraging real-world data (RWD), researchers can gain insights into the long-term effectiveness and safety of a drug across diverse patient groups.
This approach also helps identify rare adverse effects that may not have been evident in clinical trials.
Furthermore, RWS can support regulatory decisions and guide healthcare providers in making informed treatment choices.
Advances in digital health technologies and electronic health records have significantly enhanced the collection and analysis of RWD.