The Food and Drug Administration should do more to ensure clinical-trial sponsors investigate and disclose their researchers financial conflicts of interests, according to a report released by HHS inspector generals office.
Current FDA rules require clinical-trial sponsors to collect and submit financial-disclosure information on their investigators as part of the product marketing application, but the FDA often fails to follow up on incomplete disclosure information or investigate the effects of potential conflicts of interest on clinical-trial outcomes, said officials at the inspector generals office.
The review found that only 1% of researchers listed as investigators on clinical trials during 2007 disclosed they had conflicts of interest. Forty-two percent of FDA-approved marketing applications were missing required financial-disclosure information, and the agency failed to document a review of any reported conflicts of interest in 31% of applications. Whats more, neither the FDA nor clinical-trial sponsors took action to minimize potential investigator bias in 20% of marketing applications that disclosed financial conflicts.
Inspector generals office officials have recommended the FDA take several steps to disclose and mitigate researchers financial conflicts, including requiring clinical-trial sponsors to submit financial-disclosure information as a part of the pretrial application process; updating due-diligence requirements for trial sponsors; and providing additional conflict-of-interest guidance and training to product-approval reviewers.
FDA officials agreed with most of the recommendations, according to the report, but rejected the one that would require sponsors to disclose their investigators financial conflicts as a part of the pretrial approval process.