FDA: Researcher Endangers Patient in Phase III Trial

A clinical investigator failed to report an adverse event in a drug clinical trial and kept the patient in the study, endangering her safety, according to an FDA warning letter. The patient was participating in a Phase III trial conducted by Lynette Stewart of the Georgia Center for Female Health when the patient experienced an adverse event that appeared in a tissue biopsy six months after the trial began. Stewart did not report the adverse event and did not eliminate the patient from the study as she should have done, according to the warning letter.
Clinical Trials Advisor