NCCN Guidelines for Patients® | Melanoma - page 43

NCCN Guidelines for Patients
®
Melanoma, Version 1.2014
41
4
Overview melanoma treatments Clinical trials
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 book are now widely used to help
patients.
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 treatment:
Phase I
trials aim to find the best dose and way to
give a new drug. After the optimal dose and way to
give a drug is found, it may be studied in a phase II
trial if there is strong enough evidence that the drug
will be effective.
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. 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 side effects, 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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