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

iculties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies.

The final document reflects public input gathered in 2006 after release of a draft of the guidance.

Health care payers are also contemplating the role Bayesian methods could play in making coverage decisions. In a June 2009 public meeting, the Medicare Evidence Development & Coverage Advisory Committee encouraged Medicare policymakers to consider Bayesian approaches when reviewing trials or technology assessments during the national coverage analysis process.

Guidance for Use of Bayesian Statistics in Medical Device Clinical Trials

http://fda.gov/FDAgov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071072.htm?SSContributor=true

For more information about Medicare's national coverage analysis process

http://www.cms.gov/coveragegeninfo/

Media Inquiries: Karen Riley, 301-796-4674;

SOURCE U.S. Food and Drug Administration
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