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A clinical trial is a research study to answer specific questions about new
treatments or vaccines for a health-related condition, such as drug addiction.
Clinical trials are used to determine whether new drugs or treatments are both
safe and effective. Clinical trials are also used to determine the best way to
use a standard treatment.
All clinical trials are based on a set of rules called a protocol, which describes
what types of people may participate, the schedule and doses of the treatment,
and the length of the study.
Clinical trials for medications proceed through four phases:
 In Phase I clinical
trials, researchers test a new medication or treatment in a small group of people
(20-80) for the first time to evaluate its safety, determine a safe dosage range,
and identify side effects.
In Phase II
clinical trials, the study medication or treatment is given to a larger group
of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III
studies, the study medication or treatment is given to large groups of people
(1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that will allow the drug or
treatment to be used safely.
Phase IV studies
are done after the medication or treatment has been marketed. They collect information
about the effect of the treatment in various populations and side effects associated
with long-term use.
Stages of Research Using Behavioral Therapies
Behavioral therapies including drug counseling, psychotherapy, family therapy,
cognitive-behavior therapy, and motivation therapies are the most common forms
of treatment used for drug addiction. The three stages of behavioral research
are:
Stage I, This
includes the early phases of development and pilot testing of behavioral interventions.
Stage II, This
consists of efficacy testing of promising therapies, and can be aimed at determining
the mechanism of action of behavioral therapies.
Stage III, This
research consists of studies to test if and how behavioral therapies can be transported
to community settings.
Choosing to participate in a clinical trial is an important personal decision.
It is often helpful to talk to your health care provider, family members, or friends
about deciding to join a trial.
Why clinical trials are important. One of the most important reasons for participating
in a clinical trial is the knowledge that you are contributing to the development
of new treatments for people who suffer from the same condition you have.
How you can benefit. By participating in a clinical trial, you can 1) have
an active role in your treatment, 2) gain access to new treatments that are not
available to the public, and 3) obtain expert medical care at leading health care
facilities during the trial. On the other hand, the treatment you receive may
have side effects, it may not be effective for you, and it may require a lot of
your time. You need to weigh these risks and benefits.
How you are protected. The government has strict guidelines and safeguards
to protect people who choose to participate in clinical trials. Every clinical
trial in the United States must be approved and monitored by an Institutional
Review Board (IRB) to make sure the risks are as low as possible and are worth
any potential benefits. The IRB members are neutral reviewers who ensure that
the study is conducted fairly.
In addition, if you are considering joining a clinical trial, the research
staff will give you informed consent documents which describe the study, including
the nature of the study, the risks involved, and what may happen to you during
the study. The informed consent also explains that you have a right to leave the
study at any time. You may want to take these forms home and discuss them with
your family or health care provider. You should feel free to ask the research
team any questions before, during, or after the study. You may leave the clinical
trial at any time. However, let the research team know why you are leaving because
it may impact on others in the study.
What can I expect?
Before you join a clinical trial, you must qualify for the study; this decision
is based on factors such as age, type of dependence, medical history, and current
medical condition. These criteria help ensure that researchers will be able to
answer the questions they plan to study.
At the beginning of your participation, a team of researchers and health care
providers will check your health and give you instructions about your responsibilities.
They will also monitor you during the study and stay in touch with you after the
study. Some trials involve more tests and visits than you would normally have
for your condition. Your cooperation is needed in order for you to complete the
study safely.
You may be assigned (or randomized) to a specific study group. This means that
you might receive the care you would normally receive (called standard care),
or the experimental treatment (the treatment or medication being studied). If
the study is blinded, or masked, you will not know which group you are in. Blinded
studies are performed so that the patients’ and/or the doctors’ expectations
about the experimental treatment cannot influence the outcome.
What questions should I ask?
If you decide to join a clinical trial, the next step is to contact the study
research staff and ask your questions. You might want to bring a friend when you
meet with the research staff or write down your questions ahead of time. Some
sample questions you might ask are:
What is the
purpose of the study? Why does the research team think the treatment or medication
will work?
How long will
the study last?
Where is the
study site? How often will I need to go there?
Will I have
to pay anything to participate in the study?
What kinds of
therapies, procedures, and/or tests will I have during the trial?
What are the
risks, side effects, and benefits of the study compared with standard treatment?
Will I be reimbursed
for any expenses?
Will I be able
to take my regular medications during the trial?
Can anyone find
out that I am participating in a study?
Can I talk to
other people in the study?
Who will provide
my medical care after the study ends?
Where can I go for more information?
For more information on the National Drug Abuse Treatment Clinical Trials Network,
visit the NIDA website at www.drugabuse.gov
For information on other clinical trials, the National Institutes of Health
(NIH) has created a website to help patients, family members, and the general
public obtain information about government sponsored clinical trials. You may
log on to www.Clinicaltrials.gov to
learn about ongoing or new trials for all types of health related conditions.
The descriptions for individual trials include eligibility criteria, purpose of
the trial, location, and how to apply if interested. The website is maintained
and updated regularly by the National Library of Medicine.
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