Skip to content

Regulators Support ‘Pragmatism’ in Clinical Trials

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.

Related Blog Posts

Enough, already: the problem with clinical trial data collection

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…

2026 DIA Global Annual Meeting: What the FDA’s Real-Time Data Push Actually Means for Sponsors and CROs

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…