TY  - JOUR
T1  - AS use of foreign drug trials grows, fda oversight may not be keeping up
AU  - Mitka M
Y1  - 2010/08/25
N1  - 10.1001/jama.2010.1194
JO  - JAMA
SP  - 843
EP  - 844
VL  - 304
IS  - 8
N2  - 
The report, issued June 22 by the US Department of Health and Human Services' Office of Inspector General (OIG), noted that in fiscal year 2008, 80% of marketing applications for drugs and biologics approved for US use contained data from foreign clinical trials, and more than half of clinical trial participants and sites were located outside of the country. But the OIG found that the FDA was able to inspect only 0.7% of such trial locations, compared with 1.9% of domestic clinical trial sites (http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf). The OIG also reported that reliance on foreign trials by pharmaceutical interests appears likely to increase.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2010.1194
UR  - http://dx.doi.org/10.1001/jama.2010.1194
ER  -