|
|
|
 |
|
|
|
|
Adverse Event – An adverse event is any undesirable experience
that happens to a patient during a clinical trial, whether or not considered
to be related to the investigational product. It is important that all
adverse events be reported by the patient so that they can be recorded and
taken into consideration by the sponsor when evaluating the results of a
trial.
Baseline – Clinical trials are designed
to show how a person changes when given a study drug, a standard treatment,
or a placebo. An initial measurement or observation taken before treatment
is given is considered a baseline value. This may be a simple measurement,
such as a blood test result, or it may be the results of a diary kept by the
patient for several weeks before starting treatment.
Control Group – Modern drug studies are
usually designed to compare the response of a group of people who are given
the investigational medication (treatment group) with another group who are
given either a placebo or a standard treatment (the control group).
Double-Blind Study – A single-blind
occurs when the study participant does not know whether they are in the
treatment group or the control group of a study. When neither the patient,
nor the doctor running the study knows which group the patient is in, then
it is considered a double-blind study. This is done so that people in the
two groups will not be treated differently in any way other than the
medication they receive. There is always a sealed record that can be opened
in an emergency to determine whether the patient is receiving the
investigational treatment.
FDA (U.S. Food & Drug Administration) –
The FDA is a government agency whose mission is to promote and protect the
public health by helping safe and effective products reach the market in a
timely way, and monitoring products for continued safety after they are in
use.
Inclusion/Exclusion Criteria – A study
is designed to test the response of a particular group of people to a
medication. The requirements used to select these people are called the
inclusion/exclusion criteria. For example, a study for postmenopausal
hormone replacement may require that a patient be at least 48 years old to
be included, and it may exclude all women who have used hormone replacement
therapy in the past 6 months.
Informed Consent Form – Participation in
clinical trials is entirely voluntary, and it is of utmost importance that
patients have available all of the information that they require in order to
make a choice whether to participate in a study. The Informed Consent Form
is a document that is designed to provide the patient with this information.
This form provides detailed information about the study and about any known
risks of the study medication. It also provides the patient with contact
information in case they need to reach the doctor running the trial in an
emergency.
Institutional Review Board (IRB) – This
is an independent group made up of both medical professionals, and
non-medical members, who are responsible for ensuring that proper steps are
taken in designing and conducting a trial to protect the safety and human
rights of the study participants. Every trial must be approved by an
Institutional Review Board before it is begun, and the name and contact
information for the IRB can be found by the patient on the Informed Consent
Form.
Open-label Trial – An open-label trial
is a study in which the investigator and the subject know the treatment
schedules, drug treatment and doses. This is the opposite of a double-blind
study. Sometimes the pharmaceutical company sponsoring a double-blind study
will make provisions for an open-label extension at the end of a study and
allow all participants to receive the study medication for a defined period
of time.
Placebo – A placebo is a substance that
is made to appear exactly like the treatment medication, but it does not
contain any active ingredients.
Principal Investigator (PI) – The
Principal Investigator is the person responsible for conducting the clinical
trial at a particular study site and for ensuring the integrity, health and
welfare of the subjects during the trial.
Protocol – The document that defines all
of the specifics of a clinical trial is the protocol. This includes the
rationale and objectives of the trial as well as the details about how the
trial is organized and how it will be conducted. The protocol must be
approved by both the FDA and an IRB before the trial begins.
Randomization – Randomization is the
process used to assign study participants to either the treatment group or
the control group. It is carried out in a way that should prevent bias from
playing a role in the selection process.
Sponsor – The clinical trial sponsor is
an individual or organization that takes responsibility for the initiation,
management and/or financing of a clinical trial. At Coastal Connecticut
Research we participate in trials sponsored by major pharmaceutical
companies.
Standard Treatment – Sometimes an
investigational medication is compared to a placebo, but often there is a
medical condition for which a certain treatment is already commonly used and
considered the standard of care. This is called a standard treatment and may
be used instead of a placebo as a basis for comparison for the study drug.
Study Coordinator (or Clinical Research
Coordinator) – The study coordinator is a nurse or other health
care professional responsible for the day-to-day organization of study
activities at a site including maintaining study files and assisting the
investigator.
Treatment Group - Modern drug studies
are designed to compare the response of a group of people who are given the
investigational medication (treatment group) with another group who are
given either a placebo or a standard treatment (the control group). |
|
|
