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Priming the Pipeline

“Kill early, kill often” urges Kenneth Kaitlin, director of the Tufts Center for the Study of Drug Development. He�s referring to the frenzy of expensive, time-consuming clinical tests that drug companies engage in, even for candidates that will obviously fail to become effective, safe, and profitable drugs. His proposed remedy? To eliminate unpromising compounds early in the process before they waste precious resources.

To gain approval and become profitable, potential products go through around 60 clinical trials; some drug candidates undergo more than 100 trials. Many of these, Dr. Kaitlin attests, are not really necessary and can be chalked up simply to poor clinical trial design. There is no denying that, despite a rising number of published results of Phase II and III clinical trials and associated expenses, there is a dwindling count of new molecular entities on the market.

In the last five years, the number of Phase III trials, which are the most laborious, expensive, and time consuming to conduct, has more than doubled, and the count of Phase II trials has increased by more than a quarter. Last year alone, the number of Phase III trials was up by a third, though the rise in Phase II trials stabilized.

The process of discovering when to terminate research seems to be different for biologics than for chemical entities. Ending the exploration of biologics, whose numbers are beginning to rival their chemical competition when it comes to new molecular entities and new drug approvals, has proven to be especially difficult. Biologics are less likely than chemical compounds to be eliminated in Phase I and II testing, but they are more likely to be disposed of at Phase III.

Overall, the chances are remarkably slim that any given drug candidate will make it through the clinical trials process to be approved. Only 22% of Phase I candidates are ever actually approved. Even those drugs that survive into Phase III have just a 57% chance of making it through the U.S. Food and Drug Administration approval process and onto pharmacists� shelves.

Copyright © 2004 Acumen Sciences, LLC, All Rights Reserved.

Additional charts accompanying text include:

FDA Approval Trends by Type of Application

Number of Published Trial Results

NDA Filing Trends by Year

Current Products in the Research Pipeline



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