The HHS' Office of Inspector General released a report finding weaknesses in the Food and Drug Administrations information systems and management process that hinder the agency's ability to oversee clinical trial inspections and the ability to ensure that human participants are protected. The OIG report focused exclusively on the Bioresearch Monitoring Programan important mechanism for protecting human subjects, according to the inspector general's office.
According to the report, the FDA inspected about 1% of all clinical trial sites from fiscal 2000 to 2005. Of these inspections, 75% were surveillance inspections, which generally target completed trials and often focus on verifying the quality of the data. Few institutional review boards were inspected as well. The report concluded that the inspector general's office does not have a mechanism to identify all clinical trials and IRBs, which oversee research involving human subjects. In addition, it lacks a comprehensive database for tracking its inspections of clinical trials, the OIG said.
Previous OIG reports found similar weaknesses. Among five recommendations, the OIG said that the FDA should develop a comprehensive internal database of all clinical trials. The FDA concurred with four of the OIGs recommendations but did not address a provision recommending the establishment of a mechanism to provide feedback regarding inspection reports and findings, the OIG said. "Data limitations hinder the FDAs ability to ensure that participants are protected from unreasonable risks," said HHS Inspector General Daniel Levinson in a news release. "Accurate record-keeping is critical to maintaining the safety of clinical trial patients."