Event: FDA CERSI Lecture Series

Thursday, July 10, 2025
3:00 PM - 4:00 PM EDT
Triangle CERSI
triangle_cersi@unc.edu

Seminar Title: Clinical Trials Using Patient Health Data: Realities and Myths

Description:
As the use of patient health data in clinical research expands, so do misconceptions about its role. In this CERSI Lecture, Dr. Frank Rockhold, Professor of Biostatistics and Bioinformatics at Duke University, will examine the realities and myths surrounding real-world data (RWD) in clinical trials. He will discuss the regulatory landscape, key characteristics of RWD, and clarify the distinction between traditional randomized controlled trials (RCTs) and pragmatic trials—both of which are grounded in real-world practice. The talk will include examples and conclude with practical recommendations. 

This event is part of the FDA’s CERSI Lecture Series, which highlights emerging scientific approaches that support regulatory decision-making. Visit the FDA website for more information. 

Speaker Bio:
Frank W. Rockhold, PhD is Professor of Biostatistics and Bioinformatics at Duke University, with extensive experience in industry and academia, including leadership roles in global pharmaceutical research and clinical trial design. He is a fellow of both the ASA and DIA and a thought leader in real-world evidence and regulatory science.

Click on the image below to listen to the recording.