Hear this panel's discussion on the strategic use of external control arms and, if done correctly, how they can help bring products to market in a shorter time and for lower costs.
Alternatives to randomized control arms have been hotly debated since the emergence of randomized controlled clinical trials (RCT). Historical controls, synthetic controls, and external controls are among the options often discussed. This expert panel reviews the latest FDA guidance and definitions surrounding the different types of external control arms. Cardinal Health Real-World Evidence and Insights share their own methodological approach to generating real-world evidence (RWE) with fit-for-purpose real-world data (RWD), including several case studies of recent research, and highlight the importance of data completeness for external control arms.
Key Topics Include:
- Review recent FDA guidelines on real-world evidence as it relates to external control arms
- Set straight the three types of control arms – historical, synthetic, and external control arms – and discuss future trends in each
- Share the journey for a solution to RWD challenges in external control arms, including recent case studies reflecting the importance of data completeness
Presenters
Senior Director, Business Development
Real-World Evidence and Insights
Cardinal Health
Chief Medical Officer
Real-World Evidence and Insights
Cardinal Health
Director, Research Analytics
Real-World Evidence and Insights
Cardinal Health
Scientist, Scientific Operations
Real-World Evidence and Insights
Cardinal Health