The Minnesota Legislative Auditor’s second look at the University of Minnesota’s psychiatric drug trials found flaws with how researchers report adverse medical events.
Released Thursday, the report focused on adverse events during clinical drug trials, which could include patient hospitalization, disruption of normal life activities and death. Though the report found no deaths of psychiatric drug study participants other than the 2004 suicide of Dan Markingson, it did reveal inadequate reporting practices for serious medical events.
“The good news is that we didn’t find another death, but we found a lot of weaknesses and shortcomings in the reporting of adverse events,” Legislative Auditor Jim Nobles said.
University researchers sometimes didn’t report adverse events in a timely manner, and when reported, accounts often didn’t include important details about the nature of the event, according to the auditor’s review.
The auditor was unable to determine the number of adverse events that occurred because researchers haven’t always provided information about participants who drop out of studies due to adverse events.
The report recommended three steps the University could take to improve its reporting, some of which are already being implemented, said Brian Herman, Vice President for Research.
Among the recommendations are timelier reports of adverse events to the school’s Institutional Review Board, a requirement for researchers to give more detailed reports and a better definition of which events must be reported.
Despite the faults the review uncovered, Herman said, he was pleased the auditor found no instances of researchers or the University breaking federal guidelines or policies. Herman said the report was “well-balanced and fair.”
Triggered by more than a decade of intense scrutiny of research ethics at the University, Nobles’ report was the fifth this year that uncovered problems with University oversight of some drug trials, especially those conducted within the Department of Psychiatry.
Herman said the University’s recent actions amid criticism show its commitment to protecting clinical study participants.
“People will see [that] actually, we’ve been responsive. We’ve taken this seriously,” he said.
Still, Nobles said he plans to continue to monitor drug trials at the school.
“This will not be the last time that we take a look to see if the University is improving,” he said. “We will want to verify that some of what the University is reporting is
actually taking place.”
Since the release of an externally managed report in February and Nobles’ first audit in March, the University has approved dozens of steps to better protect patients while they’re enrolled in University drug studies.
The new safeguards are expected to take up to a year to implement. They are estimated to cost an additional nearly $8 million in the first year and about $2.2 million each year after.
