Less than 5% of patients participate in clinical trials today; a statistic that has remained virtually unchanged for more than two decades despite massive advances in science and technology.

In this episode of Early Signals, Dr. Wael Harb sits down with Kent Thoelke, Founder and CEO of Paradigm Health, to explore why clinical research still relies on outdated workflows and how AI, electronic health records and real-time data are creating an opportunity to fundamentally redesign the clinical trial ecosystem.

Drawing on more than 30 years in clinical research, Kent explains why simply digitizing existing processes isn't enough. Instead, he argues the future lies in embedding research directly into routine patient care, using AI to identify eligible patients before they're missed, automate manual data collection and accelerate decision-making across sponsors, investigators and regulators.

The conversation also explores Paradigm's collaboration with the FDA to pilot real-time clinical trials, where AI-generated clinical signals are transmitted directly from electronic health records to support faster regulatory review and more efficient trial execution.

Whether you're leading oncology development, clinical operations or regulatory strategy, this episode offers a practical look at how AI may reshape the future of clinical research—not by replacing people, but by removing the operational barriers that keep patients from accessing clinical trials.

In This Episode, You'll Learn:

• Why clinical trial participation has remained below 5% despite decades of innovation
• How AI and large language models are transforming patient identification and trial matching
• Why community health systems may hold the key to expanding oncology research access
• How AI-powered electronic health record integration can automate clinical trial data collection and reduce manual workload
• What the FDA's real-time clinical trial initiative could mean for sponsors, regulators and patients
• Why the future of clinical research depends on redesigning workflows rather than simply digitizing existing processes
• How AI could reshape drug development over the next five years—from smarter trial execution to more predictive development strategies

The views expressed in this podcast belong solely to the speakers and do not represent those of their organization.

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