Blinded - to make certain that a clinical trial produces good
results, under the best circumstances, both the investigator and the
patient/volunteer are "blinded"; therefore, they will not know which
treatment the patient is getting until the study is over.
Clinical investigator - Usually a doctor, this is the individual who
directs the clinical trial and is responsible for directing your study.
Clinical research coordinator - A nurse or other health care
professional who assists the principal investigator in conducting the
trial.
Clinical trial - A scientific study that tests the effectiveness of
a new medical treatment, drug or device in patients and volunteers.
Informed consent - The complete and open discussion of a clinical
trial between the investigator(s) or research team member(s) and the
patient/volunteer, during which all benefits, risks, procedures and
expectations are explained. The FDA requires that this must occur
before a patient/volunteer signs an informed consent form agreeing to
participate in the trial.
Institutional Review Board for Health Sciences Research (IRB-HSR),
previously known as the Human Investigations Committee (HIC) - a
committee of health care professionals and local citizens that monitors
all clinical research trials being conducted in an institution.
Protecting the safety and rights of participants is the primary purpose
of this group.
Open Label Study - A trial in which treatment is known to both the subject and investigator(s)
Placebo - An inactive form of treatment that has no effect, sometimes called a "sugar pill."
Research assistant - A nurse or other health care professional who
assists the clinical investigator(s) and coordinator(s) in running a
trial.
Sponsor - usually a pharmaceutical, drug or medical device company
that wishes to investigate the effectiveness of a new product and
financially supports the investigation.
Standard treatment - Any treatment for a disease or condition that is
currently in wide use and approved by the FDA. Clinical trials compare
a new treatment to the standard treatment. If no prior treatment
exists, a clinical trial will regard the lack of any treatment as the
standard treatment.
Subject - The patient/volunteer who participates in a trial.
U.S. Food and Drug Administration (FDA) - The government agency that
sets guidelines on the testing, manufacture and use of new medical
drugs, treatments or devices before they can be used by the general
public.
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