Lengthening pipeline in clinical trials

NEWS IN BRIEF — Posted Nov. 21, 2005

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Longer clinical trial phases are lengthening the time it takes to bring new prescription drugs to market in the United States, according to a recent analysis by the Tufts Center for the Study of Drug Development, in Boston.

The study found that new medicines required an average of 8.5 years to move through the clinical and approval phases in the 2002-04 period.

The number of new drugs approved by the Food and Drug Administration has fallen, and the average clinical times for priority drugs are at their longest since before enactment of the Prescription Drug User Fee Act of 1992, said Kenneth I. Kaitin, PhD, director of the center.

"As drug development becomes more complex and expensive, developers tend to concentrate available resources on fewer projects," he said. "Fewer development projects, in turn, lead to fewer new drug approvals."

Note: This item originally appeared at

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