May 2020 Volume 42, Issue 5, p729-958, e87-e100
Use of Real-world Data for New Drug Applications and Line Extensions
Winona R. Bolislis, Myriam Fay, Thomas C. Kühler
Published online: April 24, 2020
For this article, the authors compiled, summarized, and analyzed data from 27 cases in which real-world data (RWD) were applied in regulatory approval. The aims were 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.