The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce “20, 30, 40% of overall clinical trial time,” according to FDA Chief ...
Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of phase one clinical trials and applications to the FDA at the end of the ...
The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the ...
A constant influx of crime drama and trials often floods the national conversation. Some cases grip the public’s attention and leave a lasting mark on society. And we are in for a particularly busy ...
The latest episode of The Top Line, sponsored by ViiV Healthcare, features Dr. Luis Buzón, an infectious disease specialist, discussing the critical role of real-world evidence in HIV treatment and ...
Prerna Mewawalla, MD, discusses innovative strategies to enhance cancer care access, reduce clinician burden, and improve clinical trial diversity in real-world settings. As a hematologist and ...
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 ...
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
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