FDA slammed by HHS OIG for lax conflict-of-interest oversight

A new report from the HHS inspector general's office comes down hard on the FDA, arguing that the agency isn't doing enough to make sure clinical-trial sponsors stay on top of their researchers' conflicts of interest. In its recent review, only 1 percent of researchers listed as investigators on clinical trials during 2007 disclosed conflicts, the OIG found.

Right now, FDA rules require clinical-trial sponsors to turn over financial disclosure information on their investigators when they submit product marketing applications. However, the FDA doesn't do a good job of following up on incomplete disclosure information, the report said. In fact, 42 percent of FDA-approved marketing applications reviewed by the OIG were missing required financial-disclosure information.

What's more, the agency hasn't been investigating what effect potential conflicts of interest might have on clinical trial outcomes, HHS said. Neither the FDA nor clinical-trial sponsors took any actions to minimize potential investigator bias in 20 percent of the marketing applications disclosing conflicts.

To learn more about the report:
- read this Modern Healthcare piece (reg. req.)

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