State audit finds researchers didn’t fully report adverse events

Other than the 2004 suicide of a patient, the report found no deaths linked to participation in a University psychiatric drug trial.

Christopher Aadland

The second review of the University of Minnesota’s psychiatric drug trials by the state’s legislative auditor found researchers often inadequately reported serious medical events with study participants, according to a 20-page report released Thursday.

University researchers often weren’t required to report adverse events — which could include hospitalization, disruption of normal life activities and death while enrolled in a clinical trial — in a timely manner, and when reported, events often didn’t include important details about the nature of the adverse event, the report found.

 “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.

But besides the 2004 suicide of Dan Markingson, who was enrolled in a University psychiatric drug study when he died, the report didn’t find any additional deaths of patients who were enrolled in a University psychiatric drug study.

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.

The audit recommended a number of steps the University could take to improve its reporting of adverse events.

Among the recommendations are speeding up reporting of adverse events to the school’s Institutional Review Board and requiring researchers to give more detailed reports.

In a letter to Nobles, University Vice President for Research Brian Herman said the school has already started implementation of new safeguards.

Since the release of Nobles’ first audit in March, the University suspended enrollment in psychiatric drug trials and has approved dozens of steps to ensure patients are better protected while enrolled in University studies.