What is a Research Study?
A research study (also known as a
clinical trial) is a study in which people volunteer to test a new medical treatment. By
conducting research studies, we learn whether new medications are safe and effective.
Also, currently approved medications may undergo testing for the treatment of new
indications. Research studies are needed to develop new medications for many conditions,
including: high blood pressure, arthritis, migraines, reflux, diabetes, insomnia,
Alzheimers, etc. Once a new drug is found to be safe and effective, it may be
approved by the FDA for doctors to prescribe.
Why should you join a research
gain access to new research treatments and help others by contributing
to medical research.
Who can participate in a research
All research studies have certain
requirements which must be met for eligibility. These requirements may include factors
such as age, gender, type of disease, current medication use and other medical conditions.
How does a research study work?
Research studies are supervised by
qualified doctors and researchers who work as a team with other doctors, nurses and health
care professionals. If you are interested in participating in a clinical trial you will
meet with someone from the study team who will explain and discuss the study with you. If
after the discussion you want to participate in the study, the study team member will give
you an informed consent document to read and sign.
The informed consent describes what you
can expect from your participation in the study such as the frequency of the study visits,
what procedures will be done during the study, any potential benefits and possible risks
of participating in the study. It is very important that you take your time and read the
informed consent document carefully. If you have any questions regarding the document, you
should discuss them with the study doctor and study coordinator. Once you are satisfied
that you understand all of the information given to you and that all of your questions
have been answered, you will be asked to sign the informed consent document.After signing
the informed consent, information will be obtained from you to see if you meet the
requirements for study enrollment. Once eligibility is confirmed you will be enrolled in
You should note that different studies
have different requirements, but generally during the study you can expect:
To be assigned to a group that is
given the study drug or to a group that is given a
placebo (an inactive product, like a sugar pill)
Your medical history to be reviewed
To have a physical exam
To have your blood drawn for study specific tests
To be asked to complete several study visits
Your health to be checked throughout the time you are in the study
What questions should I ask?
It is important that you know as much as
possible about the clinical trial so that you can make an informed decision as to whether
or not you want to participate.
Here are some questions you may want
What is the purpose of this
How long will I be in the study?
What kinds of tests and procedures are involved in the study?
Is there a chance I will receive a placebo (inactive substance)?
Can I leave the study at any time?
Will my records be kept confidential?
How do the risks, side effects and benefits in the study compare with the current
Are there alternative treatments available?
Who will pay my medical bills if I am injured during the study, and who should I
contact if I am injured?
The answers to these questions can also
be found in the informed consent. When considering whether or not to participate in a
research study, you may request a copy of the informed consent for your review and to
discuss with your physician, family and friends.
Are research studies safe?
Researchers, doctors, and other health
professionals conduct research studies according to strict rules set by the Food and Drug
Administration (FDA). The FDA created these rules to protect clinical trial participants
and to make sure they are treated as safely as possible. research studies are also
overseen by medical ethics groups to ensure that study participants are treated
What are the benefits of
participating in a research study?
By participating in a clinical trial you
will get study related materials and medical care during the trial, have access to new
research treatments, and help others by contributing to medical research.
Can I leave a research study once
it has begun?
Yes. You are free to leave the trial at
any time. If you do decide to leave, you should let the study team know and tell them why
you are leaving the study. Early study termination procedures will be done to ensure your
safe exit from the study.
Where can I get more information
about research studies?
There are several organizations that
offer information about research studies. Here are a few:
- Center for Information & Study on
Clinical Research Participation (CISCRP): Web:
- ClinicalTrials.gov Their website address is www.clinicaltrials.gov
- CenterWatch: Their website address is