Industry report
Building trust in real-world evidence:
Industry insights on making data regulatory grade
The FDA has taken significant steps to support use of real-world evidence (RWE) in drug and medical device decisions, but adoption within the life sciences industry remains slower than needed to meet growing industry demands. A lack of standardization for regulatory-grade real-world data (RWD) and the unique nature of each submission contribute to this cautious pace – delaying innovation and limiting evidence for diverse patient populations.
To better understand these challenges, Truveta partnered with Citeline to survey life sciences leaders on how they define regulatory-grade RWD, where they see the greatest potential for RWE in FDA submissions, and what barriers must be addressed to accelerate adoption..
This industry report provides insight into:
- The key attributes life sciences leaders use to define regulatory-grade RWD
- The most promising RWD sources for regulatory submissions and why EHR data is preferred over claims and registries
- The primary use cases for RWE in regulatory submissions
- The biggest challenges in preparing RWD for regulatory submissions and how RWD providers can better support researchers
