The Food and Drug Administration (FDA) and pharmaceutical industry agree real-world evidence (RWE) and real-world data (RWD) both need standardized definitions as their use in clinical trials grows, CenterWatch reports.
The FDA’s Robert Temple during a recent workshop said there is “tremendous interest” in utilizing existing data in health care systems to “more efficiently generate evidence.”
“What people mean by RWE, and the specific study designs to be considered, is not clear,” Temple said. “In fact, the specifics of the data generated by [a randomized clinical trial] within a health care system could vary tremendously.”
To read the full report on CenterWatch, click here.