-Caveat Lector-

http://news.excite.com/news/r/990924/15/news-health-research

Colorado Medical Research Center Told To Halt Tests

Updated 3:13 PM ET September 24, 1999

DENVER (Reuters) - The government, concerned about how records and data are
kept, has ordered Colorado's top medical research university to stop its
federally funded clinical tests, putting a halt to thousands of studies on
everything from weight loss to diabetes prevention, university officials
said Friday.

The University of Colorado Health Sciences Center, one of the largest
medical research recipients in the United States, said audits by the U.S.
Food and Drug Administration found problems in bookkeeping, reporting and
database practices that did not meet federal standards.

It said the issues were not related to patient safety. The health sciences
center receives about $100 million a year in research funding and has about
3,200 ongoing research studies.

The university said changes were implemented after an audit, but not to the
FDA's satisfaction.

"The university is cooperating fully in resolving these concerns," said
James Shore, chancellor of the University of Colorado Health Sciences
Center.

The university said the FDA placed the restrictions on the activities of the
Colorado Multiple Institutional Review Board, which is responsible for
reviewing and approving protocols and maintaining detailed records.

On Sept. 21 the FDA ordered the health sciences center to suspend enrollment
of new patients into research using drugs or devices regulated by the FDA.

The next day the restrictions were broadened to not enrolling new patients
into studies funded by the federal government.

Thursday the federal government's Office of Protection from Research Risk
(OPRR) suggested suspending all studies until the matter is cleared up.

The research group then decided to halt all clinical studies, even ones
funded by pharmaceutical companies.

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