ARTICLES / General / Clinical
Trials Defined /
of clinical trials can be confusing or tough to
understand. In keeping with the spirit of knowing
as much as possible to make an informed decision, here
is a glossary of common clinical trial terms which may
not be so common to you.
- Clinical Investigator
The researcher who is in charge of carrying out a
clinical trialís protocol.
- Control Group
A group of patients that receives standard treatment
instead of the drug being tested. Results in the
control group and those patients receiving the newly
developed treatments are compared. If there is no
standard treatment yet, then the control group receives
- Double Blind Study
An experiment where neither the patient nor the
attending physician knows whether the patient is getting
one or another drug or dose. In blind studies,
only the patient does not know, preventing personal bias
from influencing reactions and study results.
- Informed Consent
This is a dialogue between a potential patient and the
clinical investigators where all risks, benefits,
procedures, and expectations of a clinical trial are
discussed. The FDA
requires all patients to sign an informed consent form
before participating in a trial.
- Institutional Review Board (IRB)
A group of health professionals from the trial
institution and members of the local community.
This board is responsible for seeing that there is no
unreasonable risk to the patient, and that the informed
consent process accurately informs the patient about his
or her role in the study.
- Investigational Treatment
This is the drug or device being tested during a
An inactive substance which resembles the medication
being tested, and that is given for psychological effect
or as a control in evaluating a medicine believed to be
A detailed plan carefully designed by a clinical trial
sponsor. It sets strict guidelines for a trial and
usually involves several different trial locations.
- Risk/Benefit Ratio
The relation between the risks and benefits of a given
treatment or procedure.
Methods used to establish the extent of a patientís
- Standard Treatment
A treatment, currently in wide use, and approved by the
FDA for a particular disease or illness. In some
trials involving new investigational treatments, there
may be no pre-existing treatment at all. In these
cases, the lack of any treatment is itself considered
the standard treatment. Generally speaking,
the hope is that investigational treatment will be safer
or more effective than the standard treat