Amgen and Astra launch AI-guided real-time trials; QuantHealth markets AI-driven trial design

Amgen and Astra are pursuing real-time, AI-guided trials described in connection with FDA efforts to expedite drug development using AI. The approach highlights ongoing interest in using machine learning to accelerate clinical research while aligning with regulatory timelines. The initiative signals a broader push to leverage data and analytics to speed decision-making in drug development.

QuantHealth, a venture-backed startup, claims its AI clinical simulation platform can test trial designs before trials. The reporting notes the risk that a Phase 3 trial can end up aimed at the wrong patients, the wrong endpoint, or the wrong competitive bar, illustrating why earlier design validation could improve efficiency. QuantHealth also states its platform can predict how any patient will respond to any therapy, including novel ones, potentially reducing waste in late-stage development.