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Bridget M. Kuehn

JAMA. 2009;301(7):709-710.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration (FDA) is doing too little to identify and mitigate the impact of financial conflicts of interest among researchers who conduct clinical trials of experimental drugs, biologics, and medical devices, according to a report released in January by the Department of Health and Human Services' Office of Inspector General (OIG).

Despite a 1999 regulation that requires a drug or device manufacturer to disclose the financial interests of clinical trial investigators when the company submits an application to market a product, nearly 42% of the 118 applications approved by the FDA in 2007 lacked complete financial information, the report said (http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf). Even when such information was disclosed, FDA reviewers often did not document that they had investigated the potential impact of such conflicts on trial data. Furthermore, in 20% of cases where a potential financial conflict of interest was identified, neither . . . [Full Text of this Article]

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