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Round Table Discussion Covering Special Topics and Considerations: Can We Have an Inclusive Approach to Clinical Trials and Pharmacovigilance?
Session Chair(s)
Mengchun Li, MD, MPA
Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States
Special populations have different safety considerations and are often underrepresented in clinical trials. This leads to challenges with adverse events reporting, safety profile characterization and statistical analysis which ultimately poses challenges in interpretation of data from clinical trials. In this session, we will discuss specific considerations and challenges with regards in rare disease, advanced therapies, and the transgender population. We will also discuss strategies and considerations for reaching the minority population to ensure more representative clinical trials.
Learning Objective : - Engage in an active dialogue with experts on special topics in rare disease, advanced therapies, and the transgender population
- Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials
- Recognize the need for a more inclusive approach within the drug development lifecycle
- Identify potential approaches to address safety challenges
Speaker(s)
Speaker
Cameron Zimmermann, MBA
Kite Safety and Pharmacovigilance, United States
Director
Speaker
Dyan Bryson
Inspired Health Strategies, United States
Global Strategic Solutions, Clinical Operations Lead, DEICT
Speaker
Lauren Shinaberry, MS
AbbVie, United States
Director, Clinical Data and Reporting Standards Function
Speaker
Kevin Freiert, MBA
Salem Oaks® Consulting, United States
Owner and Chief Executive Officer
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