Government Orders Duke Medical to Halt Clinical Trials
Posted May 11, 1999 7:00 a.m. EDT
DURHAM — Duke University Medical Centerhas been ordered by the government to stop accepting new subjects into most of its federally funded research projects.
The medical center says it will also halt non-federally funded research while it addresses questions about the amount of protection given to human guinea pigs.
Every year thousands of people enroll in clinical trials at the medical center. For patients it is a way to receive the latest treatments at a reduced cost. For researchers it is a way to put new medications to the test.
"Are new treatments more effective? Do they work? What are the side effects? The only way to know that for sure is to do a clinical trial," says assistant professor Dr. Herb Hurwitz.
Federal regulators have cited the institution for several problems, mostly administrative and record keeping.
Hospital officials say the problems did not put patients in jeopardy.
"At no point has there been any question of patients' safety or patient care," says vice chancellor Dr. Edward Holmes. "It has had to do with administrative oversight as it relates to out institutional review board."
Specifically, Duke was faulted for an inadequate review process, an unsatisfactory education plan, poor record keeping and insufficient staffing.
Hospital officials say they have tried to make changes since their first warning in December, but their efforts were not enough.
"I think the issue has to do with the speed at which we were moving to make the adjustments, which they wanted us to make," Holmes said. "And we are now taking steps to correct this in a way that is very appropriate."
While clinical trials are suspended, Duke will not be allowed to recruit new subjects for their studies. However, those who are on trial medication should continue taking it under the direction of their doctors.
Hospital officials hope to get permission to resume trials in a few days.