Two studies, released yesterday in the Journal of the American Medical Association and The American Journal of Therapeutics, looked at the quality of clinical trials submitted by cardiovascular device-makers to the Food and Drug Administration between 2000 and 2007. The JAMA study, done by University of California, San Francisco researchers, concludes that the studies "lack adequate strength and may be prone to bias" and the AJT study from Beth Israel Deaconess and FDA researchers adds that the trials have "poorly defined safety and effectiveness end points, poor patient accounting, and incomplete collection of important patient comorbidities" and that "women, pediatric, and nonwhite populations are underrepresented." Strikingly, the JAMA found that "of nearly 80 high-risk devices, the majority received approval based on data from a single study," adds Scientific Blogging. NPR's Scott Hensley adds that only half of the trials compared the devices to an alternative treatment or placebo and, of those, a third were compared to historical data, which is "a less-than-ideal approach."
The acting director of the Center for Devices and Radiological Health, Jeffrey Shuren, says that FDA will encourage device makers to include "more sharply defined targets" in their clinical trials, reports the New York Times.