September 4, 2018, Vol 320, No. 9, Pages 849-948
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness
Jacqueline Corrigan-Curay, JD, MD; Leonard Sacks, MD; Janet Woodcock, MD
JAMA. 2018;320(9):867-868. doi:10.1001/jama.2018.10136
In this Viewpoint, Janet Woodcock and CDER colleagues discuss recent FDA initiatives to investigate the adequacy of electronic health record (EHR) and patient database data for research purposes and to understand if and how real-world observational data might be analyzed in ways that mimic or can be as reliable as randomized trials.