As clinical research grow more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startup, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive.
CEU: 1.00 ACRP
Speakers:
Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Shannon Hillery, Manager, Accelerated Start-Up Unit, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center