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JNCI Journal of the National Cancer Institute 2003 95(23):1744-1746; doi:10.1093/jnci/95.23.1744
© 2003 by Oxford University Press
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© 2003 Oxford University Press

NEWS

For Investigational Targeted Drugs, Combination Trials Pose Challenges

Bruce Goldman

The first 10% of the full text of this article appears below.

Second in a two-part series.

In principle, combining old-line cytotoxic chemotherapies made sense. Those combinations went on to prove their worth in extensive clinical trials and are now enshrined in standard practice. Combining the new, targeted therapies often makes sense, too. But many of them have not been approved yet by the U.S. Food and Drug Administration. For clinical investigators, initiating trials of two experimental agents can be tough sledding.

"Getting access to multiple targeted drugs is not easy if they’re still experimental," said Dave Johnson, M.D., director of the Division of Hematology and Oncology at Vanderbilt University Medical Center in Nashville. "There was a day, years ago, when the only drugs worth testing were coming from CTEP [NCI’s Cancer Therapy Evaluation Program]," said Johnson. But these days, most drugs come from companies, whose corporate cultures—and in particular, their legal departments—render them reluctant to collaborations with potential competitors.

"Pharmaceutical . . . [Full Text of this Article]

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