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Gynecologic Oncology Group (GOG) Clinical Trials |
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Understanding Gynecologic Oncology Group (GOG) Clinical Trials |
Phases of GOG studies
In general, Phase I studies determine safety of a new treatment, Phase II
studies determine efficacy and Phase III studies determine superiority.
PHASE I
Phase I studies involve new treatments whose effects in humans are largely
unknown. This phase is used to determine how to use the new treatment in a safe
manner to the best effect.
Candidates for Phase I studies are usually individuals with cancers beyond cure,
but without localized growths that can be measured.
Often a Phase I study tries to determine safe doses for a new treatment. The
study begins with a low dose which is increased until side effects are
encountered.
PHASE II
Phase II studies are investigations to determine if a particular treatment whose
safety has been established has merit in treating a particular cancer. These
treatments are usually new, or they may be an application of a old drug in a new
setting.
When a Phase II study has shown that a significant effect has been achieved with
a treatment, then that treatment becomes a candidate for inclusion into a Phase
III study.
Typically, candidates for Phase II studies are individuals with cancers that
have resised the standard treatment, and which have a mass that can be measured
on an X-ray, scan, or by examination. This allows effects of the treatment to be
measured and timed.
PHASE III
Phase III involves randomized studies in which the entire group particates.
Participants with similar types of cancer are assigned to one of two or three
treatment regimens. Typically, one treatment is the standard approach and the
others are the new rivals. Assignments must be random to ensure
reliable,unbiased results. No scientifically meritorious study can be
accomplished any other way.
It is important to understand that each treatment option in the study is
considered by members of the G.O.G. to be effective and up-to-date. It is
unlikely that women who participate in any of the treatment regimens will be ill
served. Phase III studies compare how likely a treatment is to work, how long
the effects last, the short and long term side effects, the costs, etc., and
determine which treatment is better overall. |
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Source:
http://www.womenscancercenter.com/info/articles/phases.html
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