FDA perspective on clinical trial design for cardiovascular devices.
Chen
Eric
E
Sapirstein
Wolf
W
Ahn
Chul
C
Swain
Julie
J
Zuckerman
Bram
B
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D018795:Device Approval / Q000592:standards*; D004867:Equipment Design; D006350:Heart Valve Prosthesis; D006353:Heart-Assist Devices; D006801:Humans; D007373:Interinstitutional Relations; D007391:International Cooperation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D012107:Research Design; D012306:Risk; D018401:Sample Size; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*