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#110: Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
151B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-516-L04-P; CME 1.00; RN 1.00

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno

EMA Perspective
Andrew Thomson, PhD, MA, MS

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Kevin Bugin, PhD, MS, RAC


Speakers
avatar for Thomas Bognanno

Thomas Bognanno

Patient Representative, Alliance Practice, United States
Founder and Partner of Alliance Practice LLC, a firm dedicated to supporting select organizations in the trauma-informed care sector. Before retirement in 2023, Bognanno served as the Chief Executive Officer of Creating Healthier Communities for 17 years. Before that, he served as... Read More →
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer Inc, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs for small molecules and biologics. Her diverse experience... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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