FDA Warns Genentech Trial Investigator Over Data Problems

An investigator for a Phase III trial for the Lucentis macular degeneration treatment, which is sold by Genentech, has received a warning letter from the FDA for failing to follow the protocol and maintain accurate case histories of patients. And his omissions and mistakes raised concerns about the “validity, reliability and integrity of the data” that was captured at his site, according to the FDA letter. The physician, Bernard Doft, participated in the HARBOR study that compared low and high dose versions of Lucentis among patients with the eye affliction, which is a common affliction among the elderly (here is the listing on ClinicalTrials.gov). Ultimately, the trial did not provide the hoped-for results: the higher 2mg dose did not provide better visual acuity than the standard 0.5mg dose.    In any event, the FDA inspected his clinical site in Pittsburgh last September and found two subjects did not meet inclusion criteria, but were included in the study; the best corrected visual acuity test was measured by uncertified personnel in five subjects, and visual acuity examiners measured eye pressure without being masked to the study eye in nine subjects. They also found that the site failed to ensure that Genentech visual acuity worksheets accurately listed the person who conducted exams as documented in subject medical charts. There were 10 examples in which the examiner listed in the Genentech worksheets was not the person conducting the exams as documented in the ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs