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FDA’s Go-To Statistician: UW’s Fleming Holds Court At Xifaxan Advisory Committee Meeting

University of Washington statistician Thomas Fleming seems to be showing up more often on FDA advisory committees and is having an outsized impact on the meetings.

At the end of a recent FDA advisory committee meeting dealing with the thorny issue of how to design a complicated new study for an approved therapy in a new indication, a senior FDA official was overheard saying: “If you need someone to talk about clinical trials, he’s the guy.”

The person in question is statistician Thomas Fleming (University of Washington) and the trial design under review was for

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