Webinar: Beyond Accelerated Approvals: External Control Arms by InsideScientific

Beyond Accelerated Approvals: External Control Arms

About

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:

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

Andy Klink, PhD, MPH

Senior Director, Business Development, Real-World Evidence and Insights, Cardinal Health

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.

Bruce A. Feinberg, DO

Chief Medical Officer, Real-World Evidence and Insights, Cardinal Health

Bruce Feinberg, DO is nationally recognized for his expertise in specialty oncology and the business of specialty healthcare. Dr. Feinberg has been instrumental in the development of clinical pathways that aim to control costs, improve quality, and increase predictability.

Harlen Hays, MPH

Director, Research Analytics, Real-World Evidence and Insights, Cardinal Health

Harlen D. Hays, MPH leads 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 companies seeking to generate real-world evidence.

Sarah Lucht, PhD

Scientist, Scientific Operations, Real-World Evidence and Insights, Cardinal Health

Sarah Lucht is a Scientist on the Real-World Evidence and Insights team, where she supports studies on treatment patterns, safety outcomes, and clinical outcomes in real-world settings. Her research experience includes observational study design, data analysis, cancer epidemiology, environmental epidemiology, and data interpretation.

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