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Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Advanced

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

Assess 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; Determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, DrMed, MBA

Speaker

Guidances at a Glance: Modernizing Oncology Clinical Trials through Decentralized and Pragmatic Approaches
Timil Patel, MD


Speakers
ZJ

Zhanna Jumadilova

Senior Director, 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 Timil Patel

Timil Patel

Clinical Team Lead (Acting), Division of Oncology 2, FDA, FDA, United States
Timil Patel, M.D., is a medical oncologist who serves as a clinical reviewer on the Gastrointestinal Cancers and Melanoma Team in the Division of Oncology 3 at the U.S. Food and Drug Administration. His research interests include evaluating ways to modernize clinical trials and evidence... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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