Two da­ta fal­si­fiers sen­tenced to prison as FDA pledges to crack down on those un­der­min­ing clin­i­cal tri­als

A fed­er­al judge on Wednes­day sen­tenced two Flori­da-based clin­i­cal re­search site work­ers to more than two years of prison time each af­ter they fab­ri­cat­ed med­ical records to make it ap­pear as though sub­jects were par­tic­i­pat­ing in clin­i­cal tri­als. And more pros­e­cu­tions may be on the way as the FDA’s crim­i­nal in­ves­ti­ga­tions arm promis­es to haul in any­one else they find fak­ing tri­al da­ta.

The two sen­tenced — Ed­uar­do Navar­ro, a nurse prac­ti­tion­er from Mi­a­mi, to 46 months in prison, and Nayade Varona, an as­sis­tant study co­or­di­na­tor from Port St. Lu­cie, FL, to 30 months in prison — pled guilty in June and ad­mit­ted to fal­si­fy­ing da­ta in med­ical records from two clin­i­cal tri­als run by their com­pa­ny, called Tel­lus Clin­i­cal Re­search. The tri­als were in­tend­ed to eval­u­ate a drug for ir­ri­ta­ble bow­el syn­drome, al­though the US gov­ern­ment data­base of clin­i­cal tri­als did not list ei­ther one.

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