ascopubs.org

Challenges in Automating Extraction of Real-World Radiographic Images and Adverse Events: Lessons From the ICAREdata Initiative

For automated capture of end points, aims were to (1) develop and test methods to collect end point–defining image files for patients participating in clinical trials, (2) develop a data model and ...
RAPS

FDA works to advance real-world data collection in pregnancy and lactation

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and ...
JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...