Feb 3
The growing convergence between clinical research and clinical care—and ways the second Trump administration will be encouraging and supporting movement in that direction—was the topic of the opening keynote presentation made at this week’s Summit for Clinical Ops Executives (SCOPE) in Orlando. It was presented as an informal but informative dialogue between Janice Chang, CEO of TransCelerate Biopharma, and Mark McClellan, director of the Duke-Margolis Institute for Health Policy.
Read the full article from Clinical Research News here.
Clinical trials are a key tool for producing the safety and efficacy data that guide new therapies to market. Progress in clinical research relies on those who volunteer to participate, and yet, access to trials is not the same for everyone in the United States. Read the full article featuring Allison Cuff Shimooka from TechTarget…
ICH-E6(R3) represents a shift in mindset when it comes to clinical trials. Rather than trying to control every part of a trial equally, the guideline wants researchers to focus most on factors that are critical to participant safety and the reliability of trial results. It introduces the idea of “proportionality,” meaning more control is applied…
Getz, the Executive Director at the Tufts Center for the Study of Drug Development (CSDD), presented findings from a study they did with TransCelerate BioPharma, which sheds light on the volume and purpose of data collected in clinical trial protocols. His talk centered on a fundamental paradox in modern clinical research: While we have an…