On the heels of a JAMA study (which we reported earlier today), researchers from the FDA and Beth Israel Deaconess hospital released a similar paper appearing in the American Journal of Therapeutics. The report reaches many of the same conclusions as the JAMA paper, though, naturally, with a somewhat more sympathetic understanding of the FDA’s constraints.
A team led by William Maisel evaluated all 88 CV PMAs undertaken by the FDA between January 1, 2000 and December 31, 2007, including 132 clinical studies involving more than 37,000 study subjects. They found that safety and efficacy end points were “often not defined with precision” and concluded that their “study findings demonstrate that submitted studies frequently lack important details, including information about study subjects and study end point definitions.”
Study subjects were often poorly reported in studies used to support PMA applications, they noted. In more than half the cases important details relating to risk factors and demographics were lacking or incomplete. “These limitations.” they write, “challenge the creation of broadly applicable labeling and instructions for use and can make it difficult to predict ‘real-world’ device performance when a product is applied to a more diverse patient population.”
Because many device studies, unlike drug studies, are not conducive to double-blind, placebo-control study designs, “clinical evaluation of devices is more challenging.” Further, the legal requirement of a “least burdensome approach” has further hindered the FDA’s ability to impose rigorous standards.
The good news is that it appears likely that the FDA may be ready to address many of the issues raised by this study and the JAMA study: “It is expected that this quality study will enhance the ongoing initiatives to increase the quality of clinical evidence to support new cardiovascular technologies.”
The authors argue that higher standards are in the interest of nearly everyone: “well-conducted clinical trials lessen the burden on manufacturers, may accelerate the device approval process, and can benefit the public by bringing novel devices to market safely and more quickly. Manufacturers, regulators, and the clinical community must continue to collaborate to provide patients with reliable, safe, and clinically useful medical devices that meet appropriate benchmarks of clinical trial data quality.”
A New York Times story by Barry Meier was the first to report the publication of the FDA/Beth Israel Deaconess paper. Meier reported that FDA officials “said they were releasing their study earlier to rebut what they said were inaccuracies” in the JAMA paper. The FDA officials explained to Meier that the JAMA team “had applied scientific criteria used to evaluate studies of experimental drugs to trials of devices, which they said are run differently for technical and regulatory reasons.” However, the differences between the two papers are likely to appear minor to most readers of CardioBrief.
Meier quotes Redberg, who agrees that some details of the FDA criticism are reasonable, but notes the “central finding that the agency had accepted many cardiac device trials that lacked scientific rigor was valid.”
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