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| “Did
you hear they need more women for that trial?” |
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 ou
or an older relative may have been asked to become part of a clinical
trial, the scientific term for a research study with human volunteers
to answer specific health questions. Clinical trials are required
by the U.S. Food and Drug Administration (FDA) to make sure that new
medications and treatments are safe and effective for people to use.
There are different kinds of clinical trials that study: (a) prevention
options, (b) new treatments or new ways to use existing treatments,
(c) new screening and diagnostic techniques and (d) options for improving
the quality of life for people who have serious medical conditions.
Clinical trials follow a plan called a protocol. This describes what
types of patients may enter a study, the schedules of tests and procedures,
drugs, dosages, and length of study, as well as the outcomes that
will be measured. Each person participating in the study must agree
to the rules set out by the protocol.
Understand the rules
Clinical trials are run by doctors and other health professionals
according to FDA rules to make sure that people who agree to be in
the studies are treated as safely as possible. But before you decide
one way or the other about participating, here’s some important
information from the FDA:
MINORITIES AND WOMEN ARE URGED TO PARTICIPATE. In the
past, most drug testing was done on white men. Thus, important groups
of the U.S. population—women, African Americans, Latinos, Asian
Americans and Native Americans—have been underrepresented in
the testing. Because drugs work
Four
phases of testing
New drugs and treatments go through the following phases
of testing:
I Testing begins
with a small group of people (20-80) to evaluate a drug’s
safety, determine a safe dosage range and identify side
effects.
2 The drug
is given to a larger group of people (100–300) to
see if it is effective and to further evaluate its safety.
3 The drug
or treatment is now given to large group of people (1000–3,000)
to confirm its effectiveness, compare it to commonly used
treatment and collect information necessary to determine
its safe usage.
4 Testing continues
after the drug or treatment has been approved and marketed.
The purpose is to collect information about the effects
of the drug or treatment in various populations and about
any side effects associated with long-term use. |
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differently
on different people, the FDA wants individuals from as many groups
as possible to be included in clinical trials.
THE
INFORMED CONSENT AGREEMENT IS FOR YOUR PROTECTION. Before
you take part in a clinical trial, you have to sign an Informed
Consent. The information in this agreement should be clearly written
so you can understand it. If you don’t understand it, ask
the doctor or other medical person to explain it. See the last
paragraph for a list of questions to ask. Be aware that the
Informed Consent agreement is not a contract. You can leave the
study at any time, for any reason.
GIVE
THOUGHT TO THE RISKS. Many studies require that neither
the clinical trials participant nor the doctor knows whether you
are receiving the standard treatment, experimental treatment or
a placebo (an inactive substance that looks like the drug being
tested). In other words, you might be getting no treatment at all.
Some study drugs also have side effects that can be unpleasant,
serious, or even life-threatening. But because they’re new,
doctors don’t always know what the side effects will be.
Some side effects go away when the treatment is stopped while others
can be permanent. Some side effects appear during treatment, while
others may not show up until after the treatment is over. The risks
depend on the treatment being studied and should be fully explained
to you in the Informed Consent material.
For more information
To learn about clinical trials now underway, check out www.clinicaltrials.gov,
an online database from the National Library of Medicine. It provides
information about federally and privately supported clinical research
on human volunteers. The website gives each trial’s purpose,
eligibility, locations and phone numbers to call for more information.
Other sources of information include:
For cancer, call (800) 422-6237 or visit www.cancer.gov.
For AIDS and HIV, call (800) 448-0440 or visit www.aidsinfo.nih.gov.
Before you say yes, ask:
- What
is the study trying to find out?
- What
kinds of tests will I have to take while I am in the study and
what’s involved with each?
- How much
time does it take?
- How often
will I have to go to the doctor?
- Will
I be hospitalized? If so, how often and for how long?
- What
are the costs to me?
- Will
my health insurance pay for it?
- How long
will the study last?
- What
follow-up will there be?
- What
will happen at the end of the study?
- What
are my other treatment choices? How do they compare with the treatment
being studied?
- What
side effects or negative consequences can I expect from the treatment?
- What
are the risks to me if I were to get a placebo? How do they compare
with side effects of standard treatment?
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