F.D.A. Seeks to Regulate New Types of...

F.D.A. Seeks to Regulate New Types of Diagnostic Tests

There are 1 comment on the New York Times story from Sep 5, 2006, titled F.D.A. Seeks to Regulate New Types of Diagnostic Tests. In it, New York Times reports that:

The Food and Drug Administration took a step yesterday toward regulating a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.

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Grand Rapids, MI

#1 Sep 21, 2006
M.D. Anderson Cancer Center is taking a new look at how to evaluate new medicines and treatments for cancer. They are rethinking how they design and conduct clinical trials in the United States. Dr. Donald Berry, one of its scientists, feels that they should turn the 'statistical method' used to evaluate new drugs on its head because it limits innovation and learning.

They adopted the Bayesian method of science (with its algorithms) because it is more in line with how science works. They put this approach to the test with more than 100 cancer-related phase I and II clinical trials being planned or carried out using the Bayesian approach. Of course, the Bayesian method is no stranger to the technology of Cell Culture Assay Testing. In fact, it is what gives credit to the accuracy of assay testing.

Clinical trials test the efficacy (not the accuracy) of a drug. The efficacy of a drug is to produce a desired effect, which is tumor response (shrinkage). Single arm clinical trials provide the tumor response evidence that is the basis for approving new cancer drugs. The Bayesian methodology can bring some much-needed accuracy to the forefront of clinical trials.

Clearly, more effective cancer therapies are desperately needed, and after 30 years of investigation aimed at intensified multi-agent chemotherapy, we should look for other avenues of study. In an era of ever-increasing numbers of partially effective cancer therapeutics, there is an obvious need for more accurate methodologies. We cannot afford any more 'trial-and-error' treatments.


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