How many of these recruits – who were supposed to be people experiencing their first schizophrenic episode – were able to fully consent for themselves? And were they, like Markingson, under orders to stay in the trial? Stephen Olson, Markingson's treating physician and the other lead research for the CAFE study was featured in a webcast for "turning an underperforming site into a well-performing site." In an email from October 2003, Kenney mentioned the uptick in recruitment.Īnd, later that month, Dr. "By mid-2003, CAFE leaders were praising Olson and his recruiter, Jeannie Kenney, and asking them to share recruiting tips." "One-third of the U's patients for CAFE came from this unit," wrote Paul Tosto and Jeremy Olson in the St. This focus on recruitment turned things around for the trial. The focus is to identify any possible subjects that may be eligible for studies." Research staff are in contact with nurses, case managers, and attending psychiatrists daily Research staff attend morning report before inpatient rounds take place. The brief says, "All patients are reviewed for possible research candidacy. In a brief prepared for an August 2003 teleconference about the CAFE study, the University of Minnesota team described the establishment of a specialized 16-bed psychosis unit, known as Station 12, which would recruit subjects for the study. She then mentioned that the Department of Psychiatry was planning to open a specialty psychosis inpatient unit in April 2003, which would work as a recruitment vehicle. We've had none for January and that really concerns me." She wrote in an email, "So, some frustration here because we really need to get more enrollees. In late January 2003, Kenney was still worried about recruitment. He said, "My understanding was that Quintiles felt, or indicated that it is expensive to run multiple sites, and that if a site is unable to enter subjects in the study, then what they would prefer to do is work with sites that can." Charles Schulz, who helped lead the clinical trial at the University of Minnesota, elaborated on this in a deposition for the lawsuit. She wrote that she hoped "we can get CAFE up and running again."ĭr. Kenney mentioned that the study was "on hold/probation" in an email from September 2002. Struggling so hard, apparently, that the University of Minnesota site was put on probation for lack of recruitment. Kenney wrote to Quintiles, the clinical research organization, saying that her team was "definitely struggling to get patients" three months after she had started leading the efforts. This fact was acknowledged in a September 2002 email from Jean Kenney, the social worker who was coordinating the CAFE study at its Minnesota location. In an undated letter to CAFE study coordinators, Jeffrey Lieberman of the University of North Carolina, wrote that the study is "behind schedule on enrollment." Through the documents referenced below, most of which were filed as part of a lawsuit by Markingson's mom against the University of Minnesota, you can see how Elliott pieced together a picture of how a research team desperate for patients helped create a pipeline for clinical trial participants by setting up a psychiatric ward. In the case of the CAFE Study, which measured the benefits of the AstraZeneca drug Seroquel against its competitors, bioethicist and writer Carl Elliott, a University of Minnesota professor, has suggested that one of the trial participants, Dan Markingson, was urged to sign up for the trial, even though his mental illness may have precluded him from making a fully informed consent. Universities and research organizations set up institutional review boards to make sure research that involves human subjects is safe, among other things.
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