Clinical Trials
Another aspect of treatment you may want to
consider involves participation in clinical trials.
Many advances in cancer diagnosis and treatment
have grown out of research trials that enable
doctors to evaluate the effectiveness of new treatments.
A clinical drug trial is a research study that
tests an investigational new drug to see how safe
it is and how well it works on people. The Food
and Drug Administration (FDA) is the government
agency responsible for overseeing the clinical
trials process throughout the United States. You
and your doctors will discuss if a clinical trial
is appropriate for you.
There are four phases of clinical drug trials:
- Phase I: A phase I trial tests the
safety and determines the side effects of the
new drug. Increasing amounts of the drug are
given to small groups of patients to see how
people react to the drug. Phase I trials are
not meant to determine the ability of the drug
to treat the patients disease. It is possible
that the experimental drug may help the disease
but it is also possible that it will not or
even be harmful. A Phase I trial usually enrolls
only a small number of patients, sometimes as
few as a dozen.
- Phase II: After the successful completion
of phase I trials, the drug is then tested in
a larger population of individuals who are afflicted
with the disease for which the drug was developed.
Phase II trials determine the ability of the
drug to treat the disease and to better understand
the drugs side effects.
- Phase III: A phase III trial is where
the new treatment is compared with results of
people taking standard treatment, for example,
which group has better survival rates or fewer
side effects.
- Phase IV: After the U.S. Food and Drug
Administration (FDA) has approved a drug, phase
IV studies are conducted to compare the drug
to a competitor, explore the use of the drug
in other conditions, or to further study any
side effects.
Penn’s Neuro-oncology Program focuses
on phase I and phase II clinical trials for patients
with brain tumors. At times, phase III studies
may be available. The Neuro-oncology program is
a member of the New Approaches to Brain Tumor
Therapy (NABTT): A CNS Consortium. NABTT is one
of two consortia funded by the National Institutes
of Health (NIH) that are dedicated to carrying
out clinical trials of promising new drugs for
patients with brain tumors.
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