According to the OIG, the Food and Drug Administration (FDA) needs to do a better job in collecting and evaluating financial conflicts of interest information from clinical investigators. The OIG looked at the records of all 118 marketing applications approved by the FDA in 2007.
The OIG pointed out that:
One percent of clinical investigators disclosed a financial interest.
Among clinical investigators listed in financial forms, one percent disclosed at least one financial interest. This represents 206 of the 29,691 clinical investigators listed in financial interest forms. Of these 206 clinical investigators, almost all disclosed only one financial interest, with a few disclosing two or three financial interests.
FDA cannot determine whether sponsors have submitted financial information for all clinical investigators.
FDA cannot determine whether sponsors have submitted complete financial information for all clinical investigators, because it does not have a complete list of clinical investigators. In addition, FDA does not use onsite inspections to confirm that submitted financial information is complete.
Forty-two percent of FDA-approved marketing applications were missing financial information.
Twenty-three percent of approved marketing applications were missing a certification or disclosure form or required attachments. In 28 percent of marketing applications, sponsors used the due diligence exemption to indicate that they were unable to provide complete financial information. Although allowed by regulation, sponsors’ use of the due diligence exemption results in no financial information for FDA reviewers. Some marketing applications had both missing attachments and the due diligence exemption was marked.
FDA did not document a review of any financial information for 31 percent of marketing applications.
When FDA reviewers used a review template, they were more likely to document a review of financial information.
Neither FDA nor sponsors took action for 20 percent of marketing applications with disclosed financial interests.
In 20 percent of marketing applications, FDA reviewers did not take action, and sponsors did not indicate that they minimized potential bias during the clinical trials. For over one-half of these marketing applications, reviewers did not document a review of financial information. In addition, when FDA did take action, their actions were inconsistent.
OIG Recommendations:
FDA should ensure that sponsors submit complete financial information for all clinical investigators.
• FDA should use a complete list of clinical investigators to verify that sponsors have submitted financial information for all clinical investigators.
• FDA should also verify that sponsors have submitted all required attachments to financial forms.
• FDA should update guidance to sponsors regarding the due diligence exemption.
• FDA should add a review of financial information to the onsite inspection protocol.
FDA should ensure that reviewers consistently review financial information and take action in response to disclosed financial interests.
• FDA should require that all centers consistently use a template that includes a prompt to ensure documentation a review of financial information has been done.
• FDA should provide additional guidance and training to reviewers.
FDA should require that sponsors submit financial information for clinical investigators as part of the pretrial application process.
I believe we can all agree the FDA needs to tighten down their processes for collecting financial information from investigators, and companies need to be more diligent in reporting this information. Companies are putting the systems in place to help with this effort. In the short term, we should see tremendous gains in meeting these requirements.
Health and Human Services Office of Inspector General Full Report: FDA’s Oversight of Clinical Investigators Financial Information
Associated Press: FDA may miss researchers' financial conflicts