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Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.

Learning Objectives

Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.

Chair

Mehdi Najafzadeh, PhD

Speaker

Challenges and lessons in Linkage of RWD to Trials: An Academic Perspective
Elisabetta Patorno, DrPH, MD

Pragmatic approaches in hybrid designs: Industry perspective
Mehmet Burcu, PhD, MS, FISPE


Speakers
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Senior Director, Medidata Solutions, United States
Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →
EP

Elisabetta Patorno

Associate Professor of Medicine, Brigham and Women's Hospital; Harvard Medical School, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

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