NCCN Guidelines for Patients® | Melanoma - page 42

NCCN Guidelines for Patients
: Melanoma
Version 1.2013
Part 4: Overview of melanoma treatments
4.4 Clinical trials
A clinical trial is a type of research that studies a test
or treatment. Because of clinical trials, the tests and
treatments in this booklet are now widely used to help
Tests and treatments aren’t offered to all patients as soon
as they’re made. They must be tested in clinical trials
first. When tests and treatments are found to be safe
and helpful, they may become tomorrow’s standard of
care. However, there is no way to know this before the
trial is done.
Clinical trials are done in a series of steps, called phases.
This is to fully study how safe and helpful a test or
treatment is for patients. The four phases of clinical trials
are described next using the example of a new drug
Phase I
trials aim to find the best dose and way to
give a new drug with the fewest side effects. If a drug
is found to be safe, it will be studied in a phase II trial.
Phase II
trials assess if a drug works for a specific
type of cancer. They are done in larger groups of
patients with the same type of cancer.
Phase III
trials compare a new drug to the standard
treatment or a fake treatment (placebo). These are
randomized, meaning patients are put in a treatment
group by chance.
Phase IV
trials test new drugs approved by the FDA
to learn about short-term and long-term side effects
and safety. They involve many patients with different
types of cancer.
There may be an open clinical trial that you can join.
To join a clinical trial, you must meet the conditions of
the study. Patients in a clinical trial often have a similar
cancer type and general health. This helps ensure
that any response is because of the treatment and not
because of differences between patients. You also must
review and sign a paper called an informed consent form
to join a clinical trial. This form describes the study in
detail, including the risks and benefits.
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