|
What is a clinical research study?
A clinical research study is research
designed to test new medications, devices, or procedures to see if they
work and are safe. We will try to answer some questions you may have
about research and, with the assistance of your physician and family, you
can decide if you should participate in a clinical study.
|
What should I expect if I
participate in a clinical study?
To determine if a new investigational
medication is safe and effective, some study participants may take study
medication while some may receive a placebo (a pill with no active
medication). If you decide to volunteer for a clinical study, you
will learn about the potential risks and benefits of being part of the
study. Before you are able to participate in any clinical trial, you
will be given a written review of the study. This is called an
Informed Consent. This form will detail all of the
benefits and risks of participation as well as the medication and visit
requirements. The Informed Consent Form will also advise you of what
to expect from the study doctors and nurses.
|
|
As a study volunteer, you may be
asked to:
Make regular visits to the research
clinic.
Take study medication.
Have laboratory (blood) and
diagnostic (x-rays, etc.) testing.
Change your diet.
Completing a diary of your health.
Why are clinical trials important?
All medications available today have
been tested through clinical trials. Because of clinical trials, we have
more effective treatments for diseases. People are living longer and
surviving diseases such as breast cancer, HIV, and prostate cancer because
of improvements in medications and treatments.
What are my rights as a research
participant?
Before a clinical trial can begin, an
Institutional Review Board (IRB) must approve the study contents and
design. An IRB is a group that meets together to determine if the
clinical trial is safe for the research participant. The IRB also
makes sure that the study is ethical and meets strict FDA standards. The
IRB will also verify that the study physician and staff are qualified to
conduct research studies.
Members of the IRB are non-biased.
They are not allowed to be associated in any way with the clinical trial.
They are members of the community and their responsibility is to protect
the research volunteer.
Clinical research participants are
required to sign an Informed Consent Form prior to participating before
any research procedures can begin. This form describes everything that you
can expect to happen during your participation.
The form will tell you about the risks and benefits of participation.
Before volunteering for a research study, participants must understand
their rights and responsibilities.
What are the benefits of
participating in a clinical study?
Each study is different, but benefits
of participation may include any of the following:
Access to medication and medical care
from research specialists who know about your condition.
Laboratory and diagnostic services at
no cost to you.
Knowing that you are helping to
advance medical science.
Individual medical care from
experienced research staff.
What are the potential risks from
participating in a clinical study?
While there is a lot to be gained by
participating in a study, there are some possible risks:
Side effects may occur from the study
medication.
In some studies you may receive a
placebo, which contains no actual medication.
There are no guarantees that the
treatment will work.
What questions should I ask?
Choosing to participate in a clinical
research study is an important decision. Here are some questions that you
may want to ask clinical research center before you participate:
-
What is the purpose of the study?
-
Are there any benefits, risks or
discomforts involved with the study?
-
How long will I be in the study?
-
How often will I need to come in for
visits?
-
What tests will I need?
-
Is there a chance that I will receive
a placebo?
-
Have other people been treated with
this drug and what are the results?
-
Will I continue to see my own doctor?
-
What other options do I have if I
don’t volunteer for this study?
-
Will I have to pay for any
treatments?
-
Will my medical records be
confidential?
-
Has the study been approved by an
IRB?
If you are interested in learning
more about how to participate in a clinical trial, click here
|
