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An experimental hepatitis B drug that looked safe in animal trials tragically killed five of 15 patients in 1993. Now,...
- 17 April 2014 12:48 pm , Vol. 344 , #6181
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Duke Resumes Clinical Studies
17 May 1999 7:00 pm
After a 4-day shutdown by the federal government, the Duke University Medical Center in Durham, North Carolina, has been given a green light to start enrolling patients in clinical trials once more. The Office of Protection from Research Risks (OPRR), an agency at the National Institutes of Health that safeguards the treatment of patients in research, suspended federal support for clinical studies at Duke on 10 May because it found "severe deficiencies" in methods of filekeeping and protocol review (ScienceNOW, 12 May 1999).
The university's chancellor for health affairs, Ralph Snyderman, and a team of managers responded rapidly. They put together a plan to fix the problems OPRR had identified, rushed it to OPRR's offices in Bethesda, Maryland, last week, and persuaded the agency to end the shutdown.
Although OPRR fully restored Duke's research authority, it imposed some new conditions on the university. In a letter to Snyderman released on 14 May, OPRR enforcement officer Michael Carome writes that Duke must submit a complete list in 2 weeks of all trials that were suspended and, after that, file quarterly reports on its progress in improving the oversight of clinical trials. In addition, Duke has agreed to re-review more than 200 clinical protocols that were approved earlier this year under conditions OPRR judged to be "inadequate." The repeat reviews could take several weeks to complete, according to one researcher at the medical center, and may prevent some studies from returning to normal until June.