- Arne Carlson, who served as governor of Minnesota from 1991 through 1999, has joined bioethicists to demand more trial oversight at the University of Minnesota, a full auditor's report, and additional details about the death of a study subject in 2004, the WSJ's Ed Silverman reports.
- The group of ethicists is pushing to delay appointments to the university's Board of Regents until certain criteria—mainly the creation of a comprehensive auditor's report—are met.
- In 2004, a clinical trial participant, involved in an AstraZeneca-funded trial, committed suicide. Carlson and his allies have demanded a public hearing on the matter. But the University of Minnesota has countered by saying that the death has been investigated by numerous independent entities, including the FDA.
Clinical trial transparency is a hot topic. Last month, BioPharma Dive looked closely at clinical trial transparency in broad terms, focusing mainly on the role of pharmaceutical companies. But what about the institutions conducting the trials and the investigators being paid by pharmaceutical companies to conduct trials in accordance with medical protocol? What are their responsibilities? According to Carlson: Full transparency.
At the heart of this case, according to a report in the Wall Street Journal, is the Board of Regent's refusal to publicly review the 2004 suicide. The main strategy is to delay selection of a new board until the demands have been met.
All told, the overall goals of this process are to achieve more stringent, more effective clinical trial oversight at the University of Minnesota, including adherence to strict informed consent procedures and full disclosure of conflict of interest information, as well as an approach that values the role of the patient as a clinical trial participant, study subject, and human being.