While FDA guidance (“Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”) states that analyses of RWD, using appropriate methods, may in some cases provide similar ...

Ruxolitinib demonstrated sustained efficacy and improved quality of life in myelofibrosis patients in a real-world setting. The JAKoMo study reported fewer adverse events than clinical trials, ...

In this episode we are joined by Eric Fontana, VP of Client Solutions at Optum Life Sciences; Bethany Kalich, U.S. Medical Director, Cardiovascular at Amgen; and Christen Buseman, Director, IDN ...

The European Medicines Agency (EMA) uses Data Analysis and Real-World Interrogation Network (DARWIN EU), a data network that became fully operational in 2024, to generate real-world evidence on ...

Randomized clinical trials for people with non-small cell lung cancer (NSCLC) often fail to capture some of the nuances of the condition that significantly impact the quality of life for people with ...

Randomized clinical trials, which establish treatment efficacy under tightly controlled conditions, are crucial to medicine. But nuanced real-world patient data on quality-of-life changes, or what ...

In the late 1800s, the U.S. railroad system didn’t just revolutionize transportation—it catalyzed entirely new industries. Refrigerated railcars enabled a national meatpacking economy. Standard time ...

Digital patient profiles and real-world data enhance oncology trial design, patient recruitment, and reduce trial failure risks. Phesi's platform aligns trial designs with real-world data, minimizing ...

Traditionally, AI progress was constrained by one thing above all else: access to data. Not enough volume. Not enough ...