Oct 3
Over the past decade, the number of U.S. trials labeled “pragmatic” has increased significantly. Once viewed as an approach with limited applicability, pragmatic trials are being looked at as an opportunity to expand access to trials, and an efficient way to answer regulatory questions. Introducing pragmatic elements such as simplified procedures and expanding eligibility criteria make it possible to collect data at the point of care that can answer questions important to regulators while also informing clinical care decisions at the bedside.
Read the full article featuring Rob DiCicco from Healthcare Business Today here.
Every few years, the clinical research industry rallies around a new wave of innovation. From decentralised trials and digital biomarkers to AI driven automation, each wave brings genuine capability andpromise. Read the full article featuring Kelsey Jakee on page 38 here.
The clinical research ecosystem has never been more technologically capable — or more burdened by its own ambition. In December 2025, the Tufts Center for the Study of Drug Development and our team at TransCelerate published research that suggests nearly 30% of the data collected in clinical trials do not directly inform key decisions, yet patients are…
In this video interview from the 2026 DIA Global Annual Meeting, Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate’s Embedded Pragmatic Trials initiative, reframes the FDA’s continuous review expectations around real-time evidence generation and explains why quality by design—not data cleanup—is what regulators are now demanding. Watch…