Presentation
of the different phases of the clinical trial
According to Chinese and International rules, before
launching of a new oncology drug several researches
must have been carried out including different stages
of clinical trials.
What does every phase encompass?
Phase I:
Phase I of the clinical
trial consists in a dose-escalation study.
The researchers look for the safest dosage.
Phase II:
During Phase II, researchers want to determine what
the best indication is, on what kind of tumor the
treatment works and what are the potential side effects.
Phase III:
Phase III helps to confirm the results of the previous
steps thanks to a large trial of randomization
and control. The aim is to evaluate exactly
the utility and the safety of the treatment.
Phase IV:
This phase occurs after the launching of the product.
At least 2000 patients are monitored (according to
the State Food and Drug Administration or SFDA)
while using the new treatment to see adverse events
and confirm the efficacy in a bigger population.
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