Issue Date: January 19, 2009
FDA Not Policing Financial Conflicts In Trials
FDA is doing little to ensure that financial conflicts of interest are disclosed by investigators conducting clinical trials for pharmaceutical and medical device companies, concludes a report from the inspector general of the Department of Health & Human Services. Companies that sponsor clinical trials are required to collect financial information from the participating doctors before a clinical trial begins, but they do not have to file it with FDA until they submit an application to market the product after the trial ends. The report finds that 42% of the marketing applications approved by FDA in 2007 were missing financial information for the clinical investigators. It recommends that FDA require sponsors to submit financial information for the investigators before clinical trials begin and that the agency take action to ensure that investigator bias has been minimized when financial conflicts are reported. Of the applications that contained financial information, only 1% reported a financial conflict. In 20% of those that had a financial conflict, sponsors did nothing to minimize potential bias and FDA took no action, the report finds.
- Chemical & Engineering News
- ISSN 0009-2347
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