Back to Agenda
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 : 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.
Speaker(s)
Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno
Alliance Practice, United States
Patient Representative
Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS
Duke Clinical Research Institute , United States
Professor of Medicine; Executive Director
Panelist
Kevin Bugin, PhD, MS, RAC
Amgen, United States
Head of Global Regulatory Policy and Intelligence
Panelist
M. Khair ElZarrad, PhD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
EMA Perspective
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
Have an account?