Abstract
Approximately 25,000 patients yearly are enrolled in cancer clinical trials in the U.S.; multiple therapeutic advances have resulted. However, the trials system was cumbersome, with 2 years average time from trial design to approval, redundant, and many patients were treated to benefit few. Molecular medicine has shown that the era of the large one-size-fits-all trial is over. Biomarker screening is costly, and more patients must be evaluated to identify those meeting study criteria at a time when trial funding has decreased 20%.
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