Clinical Investigator Financial Disclosure
The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests. The OIG found that only 1% of clinical investigators disclosed a financial interest, and the FDA cannot determine whether sponsors have submitted financial interest information for all clinical investigators. Further, FDA's oversight of such information is lacking, since: almost half of marketing applications were missing financial interest information; FDA reviewers did not document a review of financial interest information in almost one-third of marketing applications; and neither FDA nor sponsors took action to minimize potential bias in 22% of marketing applications with a disclosed financial interest. The OIG recommends that FDA ensure that sponsors submit complete financial information for all clinical investigators; use a review template and provide reviewer training; and require sponsors to submit financial information as part of the pretrial application process. While the FDA generally agreed with the recommendations, it did not agree to require sponsors to submit the financial information during the pretrial application process.
