FDA outlines RWE definitions, use

In a JAMA Viewpoints piece, CDER director Janet Woodcock and colleagues reinforced FDA’s stance on the incorporation of real-world evidence into clinical trials, as well as the use of pragmatic studies pre or postmarket to collect data on optimal dosing and treatment effects in subpopulations.

In the piece, FDA defines real-world evidence as any data collected as part of routine clinical care, including electronic medical records and administrative claims data as well as data generated from personal electronic or “smart” devices, social media and socioeconomic tools...