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Volunteering for Clinical Trials |
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Your Guide to Participating in a Research Study
Over the past several years, an increasing
number of people have been interested in learning more about
clinical research and how to participate in a clinical
research study.
This page provides information about the
clinical trial process and what it means for you to
participate in a clinical trial.
What is a clinical trial?
A clinical trial is a research study to answer specific
questions about new therapies or new ways of using known
treatments. Clinical trials (also known as medical research
and research studies) are used to determine whether new drugs
or treatments are both safe and effective. Carefully conducted
clinical trials are the fastest and safest way of finding
treatments that work.
Ideas for clinical trials usually come from
researchers. Once researchers test therapies or procedures in
the laboratory and get promising results, they begin the
clinical trial. New therapies are tested on people only after
laboratory and animal studies show promising results.
What protection is there for people who
participate in clinical trials?
The government has strict rules to protect people who choose
to participate in clinical trials. These rules are set by the
Food and Drug Administration (FDA). The FDA has these rules to
make sure that people who agree to be in a clinical trial are
treated as safely as possible.
Every clinical trial must be approved and
monitored by an Institutional Review Board (IRB) to make sure
the risks are as low as possible and that the potential
benefits outweigh any risks.
An IRB is a group of physicians, community
persons and others who are independent from the study and act
to assure that a clinical trial is ethical and the rights of
study participants are protected. The IRB approves the trial
before it is started and reviews data during the study to
assure the study is being conducted in the safest manner
possible.
What is informed consent?
Before participating in a clinical trial, the research staff
will give you an informed consent form to review. The consent
form contains complete information about the trial, including
why the research is being done, the purpose of the study and
what procedures are involved. In addition, it includes how
long your participation will last, possible benefits and
risks, other treatments that are available and the fact that
you can leave the trial at any time. It is a good idea that
you take the consent form home to review and discuss it with
family members.
What are the possible risks and benefits
involved in clinical trials?
Benefits
- Gain access to new treatment not
available to the public
- Take an active role in your health care
- Obtain expert medical care and close
monitoring by research staff
- Help others by contributing to medical
research
- Receive all study-related procedures and
medications at no cost to you or your insurance carrier
Potential Risks
- Possible side effects from study
medications or treatments
- Additional time commitment for required
study visits
How to find out more about clinical
trials?
A good way to find out if there are any clinical trials that
may benefit you is to ask your doctor. We at Cardiology
Consultants of Philadelphia abide by the standards of good
clinical practice and subscribe to the highest of ethical
standards. Patient safety is paramount in all of our research
endeavors. Talk to your doctor to find out more about the
clinical trials being conducted at Cardiology Consultants of
Philadelphia.
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