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Statisticians criticise design of French trial

The Royal Statistical Society has expressed concern over the design of a French clinical trial that resulted in one volunteer’s death and the hospitalisation of five more.

In a statement published on 22 January, the RSS called for Bial—the pharmaceutical company that sponsored the trial, which was carried out by French contract-research organisation Biotrial—to release further information on the trial’s design and preliminary tests.

The society said that it had “clear statistical reservations” about the study’s design, and called on the French investigators to work with independent statisticians to assess the trial.

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