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FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
Date:2/5/2010

Agency says Bayesian statistical methods could trim costs, boost efficiency

SILVER SPRING, Md., Feb. 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies.

"This final guidance on the use of Bayesian statistics is consistent with the FDA's commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster," said FDA Commissioner Margaret A. Hamburg, M.D. "This is a terrific example of regulatory science in practice at FDA."

The FDA has substantial experience in the use of Bayesian statistical methods for the design and analysis of scientifically valid clinical studies. The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used these statistical methods.

The final guidance, titled "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials," describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and diff
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SOURCE U.S. Food and Drug Administration
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