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
Harlen Hays
Harlen D. Hays, MPH serves as the Senior Director of Scientific Operations and Research Analytics. He directs a team of senior statisticians and data scientists in the conduct of statistical analysis (and database management) of real-world data from medical chart reviews, administrative claims databases, electronic medical record databases, and other sources for biopharmaceutical manufacturers seeking to generate real-world evidence for internal and payer projects, medical communications, and regulatory bodies.
Andy Klink
Andy Klink has over 15 years of experience in academia and industry with health economics and outcomes research, multi-level mixed-effects analysis, longitudinal analysis, comparative effectiveness, and patient-oriented research. Serving as strategic scientific oversight and business development, Dr. Klink currently supports industry-sponsored research studies involving administrative claims data, electronic health records, chart reviews, and patient and physician surveys to assess healthcare resource utilization, costs, quality of life, treatment patterns, treatment response, and other clinical and patient-centered outcomes.
Sarah Lucht
Sarah Lucht is a Scientist on the Real-World Evidence and Insights team at Cardinal Health, where she supports studies on treatment patterns, safety outcomes, and clinical outcomes in real-world settings. With over 8 years working in academia and industry, her research experience includes observational study design, data analysis, cancer epidemiology, environmental epidemiology, and data interpretation. She holds a PhD in Medical Sciences from the University of Düsseldorf in Germany as well as a MSc in Epidemiology from the Harvard T.H. Chan School of Public Health.
Bruce A. Feinberg
Bruce Feinberg, D.O., is Vice President, Clinical Affairs and Chief Medical Officer for Cardinal Health Specialty Solutions. He is nationally recognized for his expertise in specialty oncology and the business of specialty healthcare.
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