Real-World Evidence Conference

Real-world Evidence (RWE) is increasingly used to support regulatory decision making, and yet a persistent gap remains between methodological intent and regulator-ready deliverables. This session will address three interconnected pillars of rigorous RWE practice that can bring success: 1. Pre-specification and execution transparency, 2. bias identification and control, and 3. the operational demands of modern RWE-enabled trial designs. We will cover a statistical analysis plan (SAP) that codes the framework to eliminate analytical drifts, negative control methodology for detecting and adjusting unmeasured confounding, and the full operational lifecycle of a regulatory RWE submission from study design through submission. An FDA representative will then walk us through a regulator’s lens, addressing where proposed approaches align with the agency’s expectations, what adjustments sponsors should consider and when to approach the agency in this process. Together, these perspectives will give you a concrete and actionable framework for designing, executing, and delivering RWE that meets the evidentiary standards regulators increasingly expect.