FAQ's For Your Medical Research Clinic Table of
Contents Glossary
of Terms Why
are clinical trials needed? Who
conducts clinical trials? Although pharmaceutical
companies sponsor (i.e. provide grant monies for) a clinical trial,
only trained doctors, nurses, and medical researchers actually
conduct the trial itself. Why
should I participate in a clinical trial? Who
is eligible to be in a clinical trial? What
is a clinical trial like? In a clinical trial, a volunteer is usually assigned to a specific study group. Sometimes volunteers in one study group will receive a new treatment or study drug. Sometimes volunteers will receive a placebo or a treatment already available. A
placebo is a harmless, inactive product used to compare the results
of the study drug. You, the study physician and the research staff
will not know who is receiving a placebo and who is not. In this
way, volunteers in a clinical trial can be observed by the physicians
and research staff more fairly, i.e. more objectively. Whether
you receive the placebo, a currently marketing medication, or
the investigational drug, the level of medical attention and care
that you receive is the same. What
is needed of me? What
can I expect from the clinical trial team? How
am I protected as a clinical trial participant? When you participate
in a clinical trial your privacy is protected. Your medical records
are confidential. The trial data that is provided to the pharmaceutical
company and the FDA will not include your name or the names of
other individuals participating in the study. Confidentiality
is just one of PRI's commitments to you!
Glossary Clinical
Trial: A scientific study that tests the effectiveness of
a new medical treatment, drug, or device with patients. Clinical
Investigator: A medical researcher in charge of carrying
out a clinical trial's protocol. Pharmacology Research Institute's
physicians are clinical investigators. Food
and Drug Administration: The government agency that sets
guidelines on the manufacture, testing, and use of drugs
and medical devices. All drugs and medical devices must be approved
by the FDA before they can be used by the general public. Informed
Consent Form: The complete and open discussion of all procedures,
benefits, risks, and expectations of a clinical trial between
clinical investigators and potential participants. The FDA
requires all participants to sign an informed consent form before
participating
in a trial. Institutional
Review Board (IRB): A group of health care professionals
as well as laypersons from the community where the clinical
trial takes place. The Board is responsible for seeing that
there is no unreasonable risk to the patient and that the
informed consent form accurately informs the participant about
his/her
role in the study, along with the potential risks and benefits
associated with one's participation. Investigational
Treatment: The drug or device being tested during a clinical
trial. Pharmaceutical
Company: A business that researches, develops, tests, manufactures,
and/or sells medical drugs and devices. Protocol: A
detailed written plan carefully designed by a clinical trial
sponsor and reviewed by the IRB, as well as the FDA. It sets guidelines
for a trial and usually involves several different trial locations. Sponsor: The
pharmaceutical company, research institution, or other health/governmental
organization that funds a clinical trial and designs its protocol. Standard
Treatment: A treatment currently in wide use (i.e. currently
marketed in the United States) 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, the investigational treatment
is hoped to be safer and or more effective than the standard
treatment(s).
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