Advanced Clinical Trials and Clinical Research

Real-World Evidence Integration

Real-world evidence (RWE) is playing an increasingly vital role in supplementing clinical trial data and supporting regulatory, reimbursement, and post-market decisions. This session explores the integration of RWE into trial design and execution, focusing on sources like electronic health records (EHRs), claims data, patient registries, and wearable devices. Attendees will learn how to design pragmatic trials, build hybrid datasets, and meet evolving FDA/EMA standards for RWE use. The session also covers statistical techniques for causal inference, bias mitigation, and external control arm creation. Through case studies from oncology, cardiology, and rare diseases, participants will understand how RWE contributes to population generalizability, faster approvals, and real-time surveillance. The session will also touch on the ethical and data privacy concerns related to real-world data use. Designed for trial designers, data scientists, and regulatory strategists, this session provides a practical roadmap to harnessing real-world insights for more effective and efficient clinical research.