FDA to device makers: Let’s get Bayesian

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.

MassDevice Staff

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.