Online Program

Return to main conference page
Friday, September 14
Fri, Sep 14, 8:00 AM - 9:15 AM
Thurgood Marshall South
Synthesize Real-World Evidence for Regulatory Decision Makings in Medical Device Clinical Studies

A Path from RWD to RWE: Stopping Over at Statistical Inference (300761)

*Scott Snyder, Cook Research 

Keywords: RWE,RWD,inference,device,regulatory,safety,effectiveness

There is great interest in generating evidence on medical device safety and performance from available real-world data. These data are “real-world” because patients are treated by numerous doctors outside of traditional closely controlled clinical studies, and lacking oversight by clinical study monitors. Statisticians are tasked with analyzing these data with the goal being to perform valid statistical inference that, at a minimum, increases the body of knowledge on the device(s), but ideally provides the basis for regulatory decision-making; i.e. a determination of safety and effectiveness. While using RWD to act as a control group through development of objective performance criteria or case-matching are thoughtful approaches, the statistician should not abandon the fundamental concepts of good study design, understanding the medical device design and usage, understanding the process of data generation, and being open to new and novel statistical methods and ways of obtaining the data. It would be through application of these fundamentals that statistical assumptions may be satisfied, inference made, and evidence generated.