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Moving Toward Pragmatism in Clinical Trials
Session Chair(s)
Zhanna Jumadilova, MD, MBA
Clinical Lead
Pfizer Inc, United States
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 Objective : 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.
Speaker(s)
Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno
Alliance Practice, United States
Patient Representative
Moving Toward Pragmatism in Clinical Trials
Jyothis George
Amgen, United Kingdom
Global Medical Vice President, Obesity and Related Conditions
Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS
Duke Clinical Research Institute , United States
Professor of Medicine; Executive Director
Moving Toward Pragmatism in Clinical Trials
Representative Invited
FDA, United States
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