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

Full interview summary

In a video interview with Applied Clinical Trials at 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, offered a pointed reframe of how sponsors and CROs should be thinking about the FDA's push toward real-time clinical trial data review. Rather than focusing on continuous data streaming to the agency, Bugin argued that the real priority is real-time evidence generation for regulatory-grade decision making—a distinction he sees as critical for how organizations should be building their infrastructure and strategies.

On data quality, Bugin pushed back on the industry's longstanding default of generating large volumes of data with cleanup built in downstream, characterizing that approach as increasingly misaligned with what regulators actually want. The message he is hearing clearly and consistently from the FDA and other global authorities is that quality must come from quality-by-design thinking—getting the right data, at the right time, in the right standard from the outset, not after a study concludes.

Bugin drew directly on TransCelerate's Embedded Pragmatic Trials work to illustrate how regulators are moving from concept to operationalization. Through multiple interactions with the FDA and other global authorities as part of the initiative's exploration of pragmatic designs and selective safety data collection, he noted that regulators are no longer debating the merits of these approaches—they are focused on execution. For sponsors and CROs, Bugin's message was clear: the conversation has moved, and the industry needs to move with it.