Division of Clinical Trials
Frequently Asked Questions
What are the benefits of volunteering to take part in clinical
research?
By participating in clinical research you may provide important
scientific information for developing new disease treatments
and further medical knowledge.
Are there risks or side effects in clinical studies?
There may be risks with any clinical study. The risks and
benefits are reviewed in detail in the informed consent process.
You are encouraged to ask questions throughout the consenting
process and while you are in the study. There are no guarantees
that the drug or device being studied will be effective.
The principal investigator or study coordinator will explain
the potential risks and the potential benefits before you
sign the consent form and join the study.
What is a human subject?
A human subject is a volunteer participant who is or becomes
involved in a research study. A subject can be either someone
who is healthy or someone with a particular medical condition.
What is a clinical trial?
A clinical trial is a research study designed to test the
safety and/or effectiveness of drugs, devices, treatments
or preventive measures in humans.
What is a blinded study?
A blinded study is done so that neither the researchers'
nor the participants' expectations about the experimental
treatment can influence the study results.
What is a clinical trial?
A clinical trial is a research study designed to test the
safety and/or effectiveness of drugs, devices, treatments
or preventive measures in humans.
What is the difference between a single and double-blinded
study?
In a single-blinded study participants do not know whether
they are in an experimental group or a control group. In
a double-blinded study, neither the participants nor the
researchers know which participants are in a group.
What is a controlled study?
In a controlled study, participants are assigned either
to an experimental group or to a control group. Participants
in the control group are used as a standard for comparison.
For example, a study may have two groups, an "experimental
group" and a "control group." The experimental group is given
the experimental treatment under study, while the control
group may be given either the standard treatment for the
illness or a placebo. At the end of the study, the results
of the two groups are compared.
How does randomization prevent bias?
Research subjects are randomized in clinical trials so that
bias does not weaken the study results. Bias refers to human
choices, beliefs or any other factor besides those being
studied that can affect a clinical trial's results. If physicians
or participants themselves choose the group, assignments
might be personally influenced and therefore unevenly slanted
toward one side or the other.
What is an experimental group?
Study participants in the experimental group receive the
drug, device, treatment or intervention under study.
What is the difference between a treatment trial and a prevention
trial?
A treatment trial tests new treatments (new drug, approaches
to surgery or radiation therapy, new combinations of treatments
or methods may also be tested). A prevention trial tests
new approaches-such as medicines, vitamins, minerals or other
supplements-that doctors believe may lower the risk of a
condition.
What is a clinical trial?
A clinical trial is a research study designed to test the
safety and/or effectiveness of drugs, devices, treatments
or preventive measures in humans.
What is a placebo?
A placebo is an inactive agent used for testing against
the active drug. The results of the active compound are compared
with the placebo to better understand the actions of the
active drug.
What can you tell me about "investigational drugs"?
The FDA has not approved investigational drugs, or they
are drugs approved by the FDA for a different purpose. In
most cases, the FDA evaluates new drugs in three separate
phases before being approved by the FDA.
What is a placebo?
A placebo is an inactive agent used for testing against
the active drug. The results of the active compound are compared
with the placebo to better understand the actions of the
active drug.
What is informed consent?
Informed consent is required for participation in all research
studies involving human subjects. Individuals are given information
about what is involved in the study, including possible benefits
and risks. Prospective study participants are encouraged
to ask as many questions as they like. Below are some examples
of the type of questions to consider before signing a consent
form.
- What is the purpose of the study?
- What type of tests and treatments are involved?
- Are there any costs involved?
- What are potential side effects?
- How could this affect my daily life?
- What is involved and for how long?
- What other choices do I have? What are their advantages and disadvantages?
Can I quit or leave a study at any time?
Yes. Participation in a research study is voluntary. You
may leave at any time for any reason. The principal investigator
can withdraw you from the study if new potential risks are
reported and if you are no longer benefiting from the treatment
If I have any questions about my rights as a research patient
whom shall I contact?
All research participants receive a copy of their signed
consent form for their own records and contact information
is in the form. If you have additional questions, contact:
Kyle Conner
Office of Human Research
(215) 503-8966
