Real World Data for Evidence Generation A Trialist's Perspective

QCOR conference chair Adrian Hernandez, MD, MHS and Bob Harrington, MD, AHA president-elect, discuss some of the insights and questions arising out of a session they participated in on using real-world data for evidence generation.

[jinyingliang]

Summary: Adrian Hernandez and Bob Harrington discuss the challenges of using real-world data and real-world evidence to make clinical decisions. They note that while clinical trials are the gold standard, they only represent a small portion of the population, leaving clinicians to make decisions on the other 98%. The discussion focuses on how to take all of the available data, analyze it, and make it usable for patients and clinicians. They note that the life cycle of medical devices is shorter than that of drugs, making it more challenging to accumulate evidence quickly. They suggest that studies need to be exponentially larger to include underrepresented subsets of the population and to account for modest treatment effects. The Apple Heart Study is cited as an example of how real-world data can be used to improve patient outcomes.