"We want to find out if they're ineffective in the smallest number of
patients and get definitive information as hervey in the development
process as possible," said Dr. Phase 0 studies expose a small number of people to low doses of a drug
over a limited period of time -- seven days or. 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' 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.
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. 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. As the name implies, a phase 0 trial precedes "phase I" testing,
traditionally the first step in the process of human drug testing. |
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