TY  - JOUR
T1  - EVidence strength in fda premarket approval of cardiovascular devices—reply
AU  - Redberg RF, Dhruva SS, Bero LA
Y1  - 2010/04/28
N1  - 10.1001/jama.2010.512
JO  - JAMA
SP  - 1599
EP  - 1601
VL  - 303
IS  - 16
N2  - 
We also agree that Bayesian methodology is an innovative way to conduct clinical trials, and we commend the FDA for issuing the 2006 guidance to reflect its consideration of Bayesian designs. However, Bayesian methodology still requires a rigorous body of evidence on which to base the prior probability estimation. We found no indication of such preexisting evidence for the innovative, high-risk devices that we studied.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2010.512
UR  - http://dx.doi.org/10.1001/jama.2010.512
ER  -