U of Minnesota called out for clinical trial practices—again
- In response to criticism of the University of Minnesota's clinical trial research practices, the university claims that its clinical trial conduct is consistent with the highest ethical standards. But a new report, released by the state legislative auditor, suggests otherwise, WSJ's Pharmalot reports.
- In 2004, an antipsychotic clinical trial participant, 26-year-old, Dan Markingson, who was involved in an AstraZeneca (AZ)-funded trial at the university, committed suicide.
- Although university officials are defending their behavior, others at the university, including bioethics professor, Carol Elliott, are pushing for more investigation and reform of clinical trial practices.
Though the infamous suicide occurred almost 11 years ago, it is still a source of inquiry and widespread concern, among professors and lawmakers, alike. A separate report has found that the university's institutional ethics committee does not have the expertise needed to review study protocols.
Moreover, there are many other red flags, including the fact that when the psychiatry department received funding from AZ to fund the trial, they had difficulty recruiting enough subjects for the study. Another challenge is that one of the study investigator's was Markingson's psychiatrists.
It seems that despite strident claims of clinical trial competency and sound bioethical behavior, the Markingson case and clinical trial conduct in general will continue to be scrutinized at the University of Minnesota for the forseeable future.