The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a report critical of FDA’s clinical trial oversight along with recommendations to improve such oversight. Congress requested the OIG report after a series of news articles published in 2005 highlighted various clinical trial vulnerabilities. The objective of the report is two-fold: (1) to determine the extent to which FDA conducted inspections of clinical trials between Fiscal Years 2000 and 2005; and (2) to assess the Agency’s process for inspecting clinical trials.
OIG found that FDA had no method in place to identify all clinical trials or Institutional Review Boards (“IRBs”), which are responsible for approving and monitoring research involving human subjects within their institution. This lack of information reportedly impeded FDA’s ability to both inspect clinical trials and to ensure that IRBs are providing appropriate oversight. The report also notes that FDA only inspected an estimated 1% of clinical trials, and that these inspections were spread across a number of different divisions within the Agency. Further, nearly 75% of the inspections that did take place occurred only after the trial concluded, and were designed to assess the quality of the data rather than the safety of the human subjects involved.
To remedy this problem OIG recommends that FDA take five steps to improve its clinical trial oversight:
- Develop a database that includes information on all clinical trials;
- Create an IRB registry;
- Create a database to allow inspection tracking between FDA components;
- Seek legal authority for clinical trial oversight; and
- Establish an institutional procedure to provide feedback to local FDA inspectors on their reports and findings.
FDA concurred in all of the recommendations, except establishing a feedback mechanism (on which the Agency did not comment).
The recently-enacted FDA Amendments Act includes new provisions intended to improve the availability of clinical trial information, including expanding the current clinical trial registry database and creating a new results database. The clinical trial database recommended in the OIG report would be a separate database for internal FDA use only.