FDA considers allowing new statistical method in medical device trials

New York, June 26 - The Food and Drug Administration is considering allowing an additional statistical method for analyzing data from clinical trials of medical devices.

The change may allow the FDA to reach conclusions from smaller or shorter trials, according to a notice announcing a public meeting on the issue.

At the meeting, scheduled for July 27, the FDA will make presentations on draft guidance and hold panel discussions. Public participation will be included.

Under the proposal, the results from trials will be allowed to be analyzed using Bayesian statistics, an approach that "provides a coherent method for learning from evidence as evidence accumulates," the FDA said. It would be valuable when there is already good information on clinical use of a device, the agency added.

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