The FDA and conflicts of interests of clinical trial investigators

A new report by the Office of Inspector General at the US Department of Health and Human Services suggests that the FDA (the US Food and Drug Administration) is not effectively monitoring conflicts of interests of clinical trial investigators in new drug marketing applications submitted to them. The report, summarised in an article on Medscape, is available here.

Its top findings were:

  • 1% of clinical investigators disclosed a financial interest
  • The FDA cannot determine whether sponsors have submitted financial information for all clinical investigators
  • 42% of FDA-approved marketing applications were missing financial information
  • The FDA did not document a review of any financial information for 31% of marketing applications
  • Neither the FDA nor sponsors took action for 20% of marketing applications with disclosed financial interests.

The top level recommendations were:

  • The FDA should ensure that sponsors submit complete financial information for all clinical investigators
  • The FDA should ensure that reviewers consistently review financial information and take action in response to disclosed financial interests
  • The FDA should require that sponsors submit financial information for clinical investigators as part of the pre-trial application process.

The report notes that “Acknowledging the burden to FDA’s administrative and review staff, we encourage FDA to develop a review of financial information that best balances the additional effort with the potential benefits.”