The U.S. Food and Drug Administration’s oversight of clinical research in hospitals and clinics has fallen considerably in recent years, due to disruptions caused by the Covid pandemic and challenges finding and keeping investigators, according to a new report by the U.S. Government Accountability Office.
In 2022, the health regulator inspected 537 hospitals and clinics that were conducting studies of medicines for which drug manufacturers were seeking approvals. By comparison, the FDA inspected 976 clinical study sites in 2017. And the FDA was unable to complete about 30% of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023.
The shortcomings are an issue because FDA inspectors visit hospitals and clinics in order to examine clinical trial protocols and records, as well as facilities involved in the research. The inspections can identify problems with data in marketing applications, which can affect approval decisions, and also spot research conduct that may pose risks to the human subjects.