Feb 5
A panel of experts from inside several major pharma companies discussed regulatory initiatives around pragmatic trials in depth at the recent Summit for Clinical Trial Ops Executives (SCOPE). “I got a fever and the only prescription is more pragmatic trials,” quipped Henry Wei, M.D., head of development innovation at Regeneron and a major fan of TransCelerate’s recent “tabletop exercise” with the U.S. Food and Drug Administration (FDA) as well as the agency’s CDER Center for Clinical Trial Innovation (C3TI) demonstration project focused on the topic.
Read the full article from Clinical Research News here.
We’ve been discussing simplifying protocol designs for decades. And yet, a phase III protocol today collects nearly 6 million data points on average; a figure that’s been climbing by roughly 11% annually. Read the full article from MedCity News here.
In a new pharmaphorum podcast, web editor Nicole Raleigh was joined by Rob DiCicco, vice president of portfolio management at Transcelerate Biopharma Inc, for a conversation on the barriers and the breakthroughs in making AI work in drug development and clinical trials. Read the full article featuring Rob DiCicco from Pharmaphorum here.
Our healthcare landscape is rapidly evolving and presenting us with complex challenges: modernizing clinical trials, ethically integrating artificial intelligence, and delivering patient-centric care. No single organization can tackle these issues alone. Read the full article from DIA Global Forum here.