ST. PAUL, Minn. (AP) — Experts conducting an external review of the clinical trial practices within the University of Minnesota have an extra month to complete their work.
The three-person panel was supposed to present its findings about trials involving human subjects to the school’s Faculty Senate last week, but was granted an extension. The review was requested by the school Senate last year in response to a decade-old controversy surrounding the death of Dan Markingson, who committed suicide while participating in an antipsychotic drug study at the University of Minnesota.
“The most important thing is to get this thing done right and an extra month doesn’t matter,” William Durfee, former chairman of the Faculty and Senate Consultative Committees, said in a letter to faculty senators. “So we were actually quite pleased that they came back with that request and didn’t try to rush things.”
The university signed a nearly $142,000 contract with the Association for the Accreditation of Human Research Protection Programs Inc. in June. The nonprofit is responsible for the management of the three reviewers selected to examine of the clinical trial practices, The Minnesota Daily (http://bit.ly/1wSueYh ) reported.
Some faculty members have voiced their concerns, saying there are potential conflicts of interest and problems with the scope of the review since it doesn’t include the Markingson case.
One of the external review panel’s experts, Jeremy Sugarman, used to work for a health care company that helped manage the drug trial in which Markingson was involved, bioethics associate professor Leigh Turner said.
The state’s legislative auditor’s office is conducting its own review of the school’s clinical trial processes. Legislative Auditor Jim Nobles said the review is expected to take several more months to complete.
Information from: The Minnesota Daily, http://www.mndaily.com/