The University of Louisville and the University of Kentucky have each signed master clinical trial agreements with Amgen, a California-based biotechnology company, as part of an effort to shorten the time it takes to move new drugs from the research stage to testing with actual patients.
Clinical trials generally take place in a four-stage process monitored by the federal government. Researchers first 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. The drug is then given to between 1,000 and 3,000 volunteers to check for side effects. In the fourth stage, the drug’s risks and benefits are studied further.
It often takes a decade or more for a new cancer drug discovered in the lab to become a Food and Drug Administration-approved medicine used to treat patients. The new master agreement trims two to four weeks off 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, according to university officials.