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Experts Urge Fixes for Clinical Trials System in 'Crisis'
Date:4/15/2010

eing trials involving more than 25,000 patients each year. It is the largest clinical trials network in the nation.

"Cooperative groups have made tremendous contributions, especially looking at new uses for approved therapies and combining novel agents that come from different sponsors, and looking at rare diseases," Mendelsohn said. "The most glorious example is all the cooperative group trials in pediatrics that led to changing the prognosis in childhood leukemia from a six months median survival to a cure rate above 75 percent."

But such victories could be in danger, a result of funding cuts, inefficiencies and other problems, the IOM report said. Since 2002, for instance, funding for the program has plummeted by 20 percent.

The report, titled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, identified four major areas of concern.

The first was the sheer amount of time it takes to set up a trial.

"We've learned that it takes more than two years for the average trial to be finalized, to write the trial," Mendelsohn said. "If a trial takes more than a couple of years to develop, it rarely finishes. It becomes out of date, new things come along. If you're going to do trials, you should be able to design them in less than a year, get them out and do them."

The second goal involves making greater use of scientific innovation -- such as biomarkers that can more quickly predict a tumor's response to a drug -- in clinical trials. That means that, instead of doing a trial on just breast cancer patients, researchers might select breast, colon and lung cancer patients who all had the same tumor mutation.

The report authors also want to explore ways in which two or three drugs could be used in combination to combat a particular type of cancer. For example, the IOM is recommending that the U.S. Food and Drug Administration help spe
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