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© Oxford University Press 2006.
NEWS |
Slow Start to Phase 0 as Researchers Debate Value
| The first 150 words of the full text of this article appear below. |
Investigators can now add another phase to their clinical trials testing. The question is how many cancer researchers will take that option?
The new choice is the so-called phase 0 trial, which allows researchers to test a small drug dose to see if it behaves as expected in humans without going through the more stringent requirements of a phase I trial. Proponents say it will quickly weed out drugs that are metabolically or biologically ineffective and give drug companies faster insight into whether to move forward with trials. Opponents, mostly cancer researchers, say it won't save money or time because scientists don't yet understand enough about how most how targeted therapies work to know whether they can even learn from low-dose tests.
Such phase 0 trials highlight a big problem in oncology drug development and may put researchers in a bind, said Richard Schilsky, M.D., a professor of medicine at
Enthusiasm Varies
Responding to Critics
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