FDA & JAMA Report Device Data Problems


A study conducted by FDA and a different study published in the Journal of the American Medical Association (JAMA) have both found problems regarding the quality of the data used to approve cardiovascular medical devices, the NY Times reported today (‘F.D.A. Seeks Better Data From Tests Of Devices,’ by Barry Meier, pageFDA device data B1). Although the researchers came to some different conclusions, both studies showed serious problems with the way clinical trials are conducted, in particular with the follow-up of study participants. I can’t do a better job of explaining it than Mr. Meier of the Times so I won’t try. The URL to his article is below.

However, I can comment on the problem of “Lost to Follow-up” in device trials. I have audited a number of clinical trials for cardiovascular devices and found attempts to follow up with seriously ill participants to be lacking. At one clinical site, patients would be released to the institution’s extended-care facility where they died from complications of the surgery or disease progression. The clinical investigators had no way of communicating with their own affiliated facility and would learn of the deaths months later, if at all. At least from my own perspective, the problems identified in the two studies are very real.

It looks like FDA will develop guidelines for tougher standards. Hopefully the discussions that result from the two different studies will help determine the best approach. The FDA study was conducted by scientists at Beth Israel Deaconess Medical Center and FDA. The JAMA published study was conducted by researchers at the University of California, San Francisco.

http://www.nytimes.com/2009/12/30/business/30device.html?_r=1&ref=todayspaper

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