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 ...
Methodological research in artificial intelligence (AI), machine learning and statistics often develops without a concrete application in mind. Many impactful advances in these fields have been made ...
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 ...
Clayton Irvine, PharmD, MBA, MS, explains that leveraging high-quality, real-world data; cross-institutional collaboration; standardized care pathways; advanced technologies; and integrated ...
The integration of real-world data (RWD) into protocol feasibility and site selection has emerged as a clinical trial game-changer in recent years. Traditionally relying heavily on data from carefully ...
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 ...
The rise in direct-to-patient therapeutics access via online compounding pharmacies and other direct-to-patient sales models has increased the likelihood of patients utilizing medications alongside ...
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