FDA Warns Genentech Trial Investigator Over Data Problems

Published: Jul 22, 2013

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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.

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