RGA 6480 — Real-World Evidence and Patient-Reported Outcomes in Regulatory Decision Making
2 semester hoursGraduateLecture
Presents an overview of real-world evidence, discusses challenges in implementing an effective RWE strategy, and reviews the implications of RWE on regulatory decision making. Topics include patient-reported outcomes, observational studies/pragmatic clinical trials, comparative effectiveness research, registries, primary vs. secondary data collection, medical claims and electronic health record data, social media, wearable devices, and artificial intelligence.