Digital platforms that could make real-world data usable
FDA-Duke meeting highlights platforms that can help drug developers leverage RWD
As real-world data grows in importance so does the need to stitch together disparate data sources in a way that makes the information usable. A recent meeting co-hosted by FDA and the Duke Margolis Center for Health Policy showcased data management systems that could make it easier for drug developers to analyze real-world data and integrate it into clinical trials.
The emergence of digital health technologies such as wearables and mobile apps, and the vast amount of real-world data (RWD) available from electronic health records (EHRs) and claims and administrative databases, has spurred industry and regulators to explore how this information can be turned into real-world evidence (RWE) to support label expansions for approved drugs and satisfy postapproval study requirements (see “Gottlieb: How a Cultural Shift is Transforming FDA’s Drug Reviews”).