FDA Sends Warning Letter to Genentech Trial Investigator

FDA Sends Warning Letter to Genentech Trial Investigator

July 17th, 2013 // 2:21 pm @

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A clinical investigator for a phase III clinical trial for a Genentech drug got a warning letter from the agency for not following protocol and keeping proper case histories of patients. The drug in question was Lucentis, and it is for macular degeneration.

FDA stated in the warning letter that the omissions and mistakes raise worries that the integrity, reliability and validity of the data at the clinical site is in doubt.

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The doctor’s name is Bernard Doft, and he was involved in the HARBOR study that was comparing high and low doses of the drug in patients who suffer from this eye disease. Macular degeneration is a common problem for elderly patients. In the end, the trial did not give results that were hope for. The dose that was 2 mg higher didn’t give any more visual acuity than a regular dose of .5 mg.

FDA conducted a GCP inspection of the site in Pittsburgh last year. It found that two of the clinical trial subjects did not meet the necessary inclusion criteria but were put into the study. A visual acuity test that was the best corrected version was taken by personnel who were unqualified. This was done for a total of five patients. Examiners who took eye pressure were not masked to the clinical study, and this occurred in a total of 9 subjects.

FDA also found that the site did not ensure that Genentech’s worksheets for visual acuity were accurately listing the person who did the exams, as was shown in the medical charts for the subjects. There were 10 instances where the examiner that was shown on the worksheets didn’t match what was written in the charts. Such violations happened with 5 of the 24 subjects that were at the clinical site.

The doctor also was cited in the FDA warning letter for not getting informed consent twice. The subjects participated in the trial and then signed the documentation at a later date. FDA auditors noted that one of the subjects was not able to read the consent form, as the form was given to the patient after her eyes were dilated.

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