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Session 4: Leveraging RWD and Synthetic Data to Advance Research in Special Populations
Session Chair(s)
Charles Lee, MBA, MS
Executive Regulatory Science Director
AstraZeneca, United States
The session will share lessons on how to incorporate synthetic data thoughtfully into RWE pipelines, particularly for sensitive, stigmatized, or underrepresented populations. Implications for research design, data validation, and convergence with traditional data sources will be discussed to ensure methodological rigor in synthetic applications.
Learning Objective : - Examine insights from a preliminary validation study on using synthetic data to test survey instruments with sensitive substance use questions
- Discuss how synthetic cohorts support feasibility assessment, hypothesis refinement, and sample size planning
- Identify methodological applications of synthetic data for accessing hard-to-reach populations, including young adults
Speaker(s)
Leveraging Synthetic Data for Methodological Insight into Substance Use Research with Hard-to-Reach Young Adults
Red Thaddeus Dela Pena Miguel, MD, MBA, MSc, RAC
Thera-Business Inc., Canada
Chief Executive Officer
Speaker
Michael Rozycki, PhD
Pacira Pharmaceuticals, Inc., United States
Senior Vice President, Regulatory Affairs
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