Governing accelerated evidence in real-time clinical trials

The FDA’s recent initiative to implement real-time clinical trials (RTCTs), with AstraZeneca’s Phase 2 TRAVERSE and Amgen’s Phase 1b STREAM-SCLC trials where real-time safety, efficacy, and operational data are transmitted to regulators, marks a consequential shift in clinical evidence 1 . Although RTCTs promise to modernize clinical development, the central concern is whether accelerating data velocity will outpace the evidentiary maturation, independent oversight, and infrastructure investment required to protect Good Clinical Practice, data integrity, and equitable participation across the full spectrum of trial sites (Fig. 1 ). These concerns are neither hypothetical nor premature. Live data are already flowing to the FDA from two operational trials, and the governance and infrastructure challenges examined here are preconditions for any trustworthy scaling of the program 2 . The best time to establish governance is now, before RTCTs scale beyond conditions that current program infrastructure was designed to handle.