UofL, UK sign deal to speed clinical trial start-ups
November 19th, 2007
Kentucky’s two largest universities have begun partnering with an international biotechnology company to move new drugs from the lab to the marketplace more quickly.
The University of Louisville and University of Kentucky each have signed master clinical trial agreements with Amgen Inc., a California-based business that operates a distribution center in Louisville. The step is intended to shorten the time it takes to move drugs from the research stage to testing with actual patients.
Kentucky has been conducting fewer clinical trials than many other states; it now has about 630 under way compared to about 1,060 in Tennessee, about 1,560 in Illinois and about 1,700 in Ohio, according to the National Institutes of Health.
It commonly can take a decade or longer for a new cancer drug discovered in the lab to become a Food and Drug Administration-approved medicine used to treat patients.
Clinical trials generally take place in a four-stage process monitored by the federal government. First, researchers test the new drug with a group of 20 to 80 volunteers. If that proves safe and effective, the drug is given to a larger group of volunteers. Then, researchers give the drug to between 1,000 and 3,000 volunteers and check for side effects. In the fourth stage, the drug’s risks and benefits are studied further.
The new master agreement trims two to four weeks from the time it takes to review and approve the terms and conditions of clinical trial agreements, an improvement that gives Kentucky a better competitive edge, said Manuel Martinez-Maldonado, executive vice president for research at UofL.
UK’s agreement applies to all clinical trials funded by Amgen at Chandler Hospital while UofL’s applies to the same at three of its affiliated hospitals, Norton Healthcare, Jewish and St. Mary’s Healthcare and University of Louisville Hospital.
The first clinical trial approved through UofL’s new agreement, a kidney disease study by nephrologist Rosemary Ouseph, already has begun at Jewish Hospital.
