Clinical Trial Expenses Swell Drug Development Costs

Compiled ByDeborah Austin Ten years ago developing a new prescription drug cost an average $231 million in 1987 dollars. Had costs increased at inflation's pace, today's average would run $318 million in 2000 dollars. Instead, the cost to develop a new drug has skyrocketed to $802 million, concludes a new study by the Tufts Center for the Study of Drug Development, Boston. Much of the increase relates to rising clinical trial costs associated with difficulty in recruiting clinical-trial patients while drug development programs are expanding, and increased focus on drugs addressing chronic and degenerative diseases, says Dr. Joseph DiMasi, Tufts Center director of economic analysis. "The single largest challenge facing drug developers -- both pharmaceutical and biotechnology companies -- is to contain R&D costs and reduce development times without compromising clinical test design," says Tufts Center Director Dr. Kenneth I. Kaitin. Compared with results for a similar study conducted 10 years ago, the inflation-adjusted R&D cost per approved new drug increased by a factor of 2.5.