BioXcel says independent audit of Alzheimer’s study found misconduct did not impact data reliability

BioX­cel Ther­a­peu­tics said Wednes­day that it still plans to use da­ta from a site in its Phase III Alzheimer’s dis­ease study af­ter the FDA cit­ed the un­eth­i­cal be­hav­ior of one of the study’s in­ves­ti­ga­tors, who fab­ri­cat­ed an email when she re­port­ed a par­tic­i­pant’s se­ri­ous med­ical event.

Ac­cord­ing to BioX­cel, the in­de­pen­dent au­dit found that the da­ta it re­viewed from the site were a rep­re­sen­ta­tive sam­ple, and the au­di­tors “did not iden­ti­fy any find­ings that they be­lieve im­pact the da­ta re­li­a­bil­i­ty or in­tegri­ty, nor did they find any ev­i­dence of ad­di­tion­al mis­con­duct or fraud.”

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