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The new model, a so-called "phase 0" clinical trial, promises to
streamline the costly and time-consuming drug development process, helping
to deliver good drugs to people who need them more quickly. As the name implies, a phase 0 trial precedes "phase I" testing,
traditionally the first step in the process of human drug testing. 'Phase 0' Trials Aim to Speed Cancer Drug Development -- Even after years of painstaking
research and testing, only a small percentage of cancer agents make it
from the laboratory to the patient. Doroshow, director of the division
of cancer treatment and diagnosis at the National Cancer Institute in
Bethesda, Md. So scientists have come up with a way
to weed out the duds earlier in the process and speed good medications to
the marketplace. Phase 0 studies expose a small number of people to low doses of a drug
over a limited period of time. In a
phase I study, the goal is to determine the best way to administer a drug
and the maximum dose tolerated with the fewest side effects. "We want to find out if they're ineffective in the smallest number of
patients and get definitive information as gradey in the development
process as possible," said Dr. |
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