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Duke Told to Stop Clinical Trials

At the behest of federal regulators, Duke University's Medical Center in Durham, North Carolina, shut down most of its government-funded clinical trials this week. On 10 May, the Office for Protection from Research Risks (OPRR), an agency of the Department of Health and Human Services that protects the rights of human volunteers in research, ordered Duke to stop enrolling new patients temporarily and to halt studies that do not directly benefit patients.

Since December, when OPRR officials made a site visit to Duke, they have been asking Duke to improve procedures designed to safeguard the rights of people who take part in clinical trials. This week, OPRR apparently lost patience with the university. In a 10 May letter to Duke chancellor for health affairs Ralph Snyderman, OPRR official Michael Carome wrote: "OPRR finds the scope and pace of [Duke's] implementation of corrective actions ... to be inadequate. Indeed, the significant lack of progress ... suggests a failure of leadership in [Duke's] human subject protection system." OPRR had asked the school to keep more extensive records on clinical trials, to develop a training program for those who review research proposals, and to create an additional review panel to monitor the growing number of clinical trials.

Although Duke and OPRR have been discussing these issues for 3 months, Snyderman says that he was "absolutely not" prepared for the shutdown order this week: To call it a surprise, he added, "would be an understatement." Duke receives about $175 million annually in federal support for clinical studies, and it supervises about 2000 trials in all. Snyderman said "hundreds" of studies have been affected by the shutdown. But he said of OPRR's decision: "I don't want to second-guess anybody." The medical center is working rapidly to satisfy OPRR, he said, and hopes to resume normal operations in a week or two.

Meanwhile, Duke is recovering from a second tragedy, which is only "coincidental" with the research shutdown, a spokesperson for the university says. Charles Putman, former medical school dean and senior vice president for research administration and policy, died of a heart attack on the evening of 10 May. Putman, 57, a radiologist and member of the Institute of Medicine in Washington, D.C., was "a national leader in research policy" and "a physician who cared deeply about his patients," said Duke President Nannerl Keohane. A university spokesperson says Putman was aware of the OPRR problem before his death, but it did not affect his area of responsibility.