Use of real-world data for new drug applications and line extensions

Use of real-world data (RWD) has been gaining attention across the regulatory industry. While the current application of RWD has been limited to specific cases, there is a potential to further explore and develop its application.

In this article published on Clinical Therapeutics we analyze data from 27 cases in which RWD were applied in regulatory approval to:

  • provide an overview of RWD, based on classifications per therapeutic area, age group, drivers of acceptability, utility, data sources, and timelines, and
  • to present insights on how it has been applied in regulatory decision making to date