In a second review of industry-funded psychiatric drug trials at the University of Minnesota, Legislative Auditor James Nobles has found lapses in reporting adverse events such as injuries, but no deaths beyond the suicide of Dan Markingson a decade ago.
While the U has taken steps to improve the speed and depth of its adverse-event reporting in the past year, the audit found multiple instances over the prior decade when reports lacked key details such as the dates when events occurred.
That’s significant, given that researchers have deadlines to report adverse events to the U’s Institutional Review Board (IRB), an internal safety and ethics panel, said Joel Alter, evaluation coordinator for the state legislative auditor. “You kind of have to know the date it occurred to know whether the researchers complied with the standards,” he said.
Some events were reported with sketchy details, or in letters instead of standardized forms, the audit found.
The U’s vice president for research, Brian Herman, said Thursday that the school already is making changes, including a more detailed form that will compel researchers to provide more information about adverse events to the IRB.
Although researchers have been thorough in reporting events to the private companies or government agencies funding their work, “they were less fastidious about reporting to our own IRB here,” Herman said. “Now reporting to our own IRB has to be just as fastidious and quick.”
Serious adverse events can include injuries, hospitalizations or significant impairments to patients who are participating in drug trials. But Nobles’ review included some oddities, including a reported 2010 incident in which a sex offender living in a Minneapolis treatment facility mixed antipsychotic medication furnished as part of a study into the breakfast oatmeal for all other residents.
Some of the reported hospitalizations and injuries appeared unrelated to the drugs patients were taking in their studies, but Alter said researchers should err on the side of providing more information about these events to the review board. “It’s important for the IRB as an independent reviewer to be able to make its own judgment,” he said.
Earlier this year, Nobles issued a highly critical audit of the U’s recruitment and treatment of Markingson in an industry-funded trial that compared three medications for schizophrenia.
The audit followed a separate, outside review that faulted the U over ethical and safety oversight of psychiatric research. The chairman of the U’s Psychiatry Department stepped down following the reports, and has since announced plans to retire, and the U suspended patient recruiting into psychiatric drug trials.
Safety reviews have allowed four studies so far to resume recruitment, and five others are close to gaining approval as well, Herman said.
The university has since unveiled a $7.8 million overhaul of its human-subject protections for all clinical research. That includes $5.5 million for an electronic reporting system of adverse events to the IRB, which Herman said will make it easier for researchers to provide depth in their reports.