The HHS Office of Inspector General (OIG) says the FDA can't determine whether clinical trial sponsors have submitted financial information for all clinical investigators due to lack of a complete list of clinical investigators. Also, the OIG said, the FDA does not use onsite inspections to confirm that submitted financial information is complete.
The statement is included in an OIG report looking at the extent and nature of clinical investigators' disclosed financial interests reported to the FDA for marketing applications approved in FY 2007. OIG analysts found that 1% of clinical investigators disclosed a financial interest (206 of the 29,691 clinical investigators listed in financial interest forms). Of the 206, almost all disclosed only one financial interest, with a few disclosing two or three interests.
Some 42% of approved marketing applications were missing financial information, the OIG reported, and the FDA did not document a review of any financial information for 31% of marketing applications.
In 20% of marketing applications, FDA reviewers did not take action and sponsors did not indicate that they minimized potential bias during the clinical trials. For more than half of those applications, reviewers did not document a review of financial information. In addition, the OIG said, when the FDA did take action, the actions were inconsistent.
The report recommended that FDA:
- use a complete list of clinical investigators to check that sponsors have submitted information for all clinical investigators;
- check that sponsors have submitted all required attachments to financial forms;
- update guidance to sponsors on the due diligence exemption;
- add a review of financial information to the onsite inspection protocol;
- require that all Centers consistently use a template including a prompt to document a review of financial information;
- provide additional guidance and training to reviewers; and
- require that sponsors submit financial information for clinical investigators as part of the pre-trial application process.
The FDA expressed concern about the OIG analysis, but agreed with all recommendations except the one that would require sponsors to submit financial information for clinical investigators as part of the pre-trial application process. The FDA said that collecting financial information before a clinical trial starts is the sponsors' responsibility, but the OIG pointed out that the FDA has no mechanism in place to ensure that sponsors are collecting financial information before beginning clinical trials.