RT Journal
A1 Chen CE, Dhruva SS, Redberg RF
T1 INclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval
JF JAMA
JO JAMA
YR 2012
FD November 7
VO 308
IS 17
SP 1740
OP 1742
DO 10.1001/jama.2012.14491
UL http://dx.doi.org/10.1001/jama.2012.14491
AB 
To the Editor: Use of a comparator group is not required in studies used for approval of medical devices, in contrast to drugs, which require 2 randomized controlled trials. The US Food and Drug Administration (FDA) defines valid scientific evidence as “partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience.”1 A study of new drugs in the United States found that 51% were not supported by comparative effectiveness data at the time of FDA approval.2 Unlike drugs, device trials frequently use control data from previous trials (historical controls) and performance benchmarks imputed from prior studies (objective performance criteria; OPC) in evaluating outcomes. However, the lack of active controls raises concerns about selection bias and validity.