title: Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval.
authors.affiliation: Department of Medicine, Stanford Hospital and Clinics, Palo Alto, California, USA.
authors.forename: Connie E
authors.initials: CE
authors.lastname: Chen
authors.forename: Sanket S
authors.initials: SS
authors.lastname: Dhruva
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D002318:Cardiovascular Diseases / Q000628:therapy*; D057186:Comparative Effectiveness Research; D035061:Control Groups; D018795:Device Approval / Q000592:standards*; D023381:Endpoint Determination; D006801:Humans; D019736:Prostheses and Implants / Q000592:standards*; D012107:Research Design; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration