07.24.26 -- Turning RWD Into RWE That Works For Trials

The 2026 Rare Trials Summit brings together senior clinical development leaders from biopharma, FDA, patient advocacy and research sites to tackle the practical barriers slowing rare disease development. Held September 14-16 at the Boston InterContinental, the Summit combines working groups, interactive workshops, and candid discussions on evidence generation, trial design, patient engagement, endpoints, and execution. The goal is simple: better decisions, stronger collaboration, and more effective rare disease trials.

Real-world data is everywhere, but turning it into real-world evidence regulators and sponsors can trust is the real challenge. Our panelists for this live event, Aaron Kamauu, MD and Kathleen Mandziuk, MPH, RN, cut through the noise to show how RWD/RWE can streamline trial design, speed timelines, and deliver real results without getting tripped up by messy data or shaky validation.

In this Q&A, Ribu Goyal, an IRB specialist and scientific reviewer at the Mayo Clinic Office for Human Research Protection, talks about everything from the details of her job to how sponsors could improve their collaboration with their IRBs.