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

Download Building trust in realworld evidence: industry insights on making data regulatory grade Whitepaper