The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation

Clinical trial data still moves much the way it did decades ago. Site staff re-enter information from the electronic health record (EHR) into a separate data capture system. Then they wait while it is cleaned, monitored, cleaned again, and finally sent to regulators. As much as half of that timeline is dead time. In this conversation, Kent Thoelke, founder and CEO of Paradigm Health, explains how the FDA's Real-Time Clinical Trials initiative, piloted with Amgen and AstraZeneca, turns that model around. The trial protocol is built directly into the EHR. Pre-agreed "signals," such as a patient being dosed, a treatment-related side effect, or a tumor shrinking, can then reach sponsors and the FDA within days, without sending mountains of patient-level data.

Kent also explains how this continuous review can speed go/no-go and dosing decisions and lighten the workload for community and rural sites. He describes how monitoring shifts from checking transcription to applying clinical judgment, and why early-phase pilots are where sponsors can help shape the standard. Watch to see how moving data review closer to the point of care can help your team cut delays, reduce site burden, and make faster, more confident development decisions.