FDA looks to speed medical device trials

February 5, 2010 by MassDevice staff

Companies looking to get medical devices to market might want to brush up on their probability theory, after the Food & Drug Administration issued new guidelines for statistical method it says can speed clinical trials.

The FDA said medical device makers can use Bayesian statistical methods to design and analyze clinical trials. Bayesian probability applies an algorithm allowing companies to combine data from previous trials with current trial data. That, in turn, could provide "sufficient justification for smaller or shorter clinical studies," according to a press release.

The federal watchdog agency said it has "substantial experience" in used the method in clinical trials and has cleared "a number" of medical devices from companies that used the method in clinical trials supporting their applications.

The Centers for Medicare and Medicaid Services are also considering the use of Bayesian probability in making coverage decisions, when reviewing trial results or technology assessments, according to the press release.

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