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They check the health of
the participant at the beginning of the trial, give
specific instructions for participating in the trial,
monitor the participant carefully during the trial
following each companies specific set of instructions.
Why participate in a
clinical trial?
Participants in clinical trials can play a more active
role in their own health care, gain access to new
research treatments before they are widely available,
and help others by contributing to medical research
Who
can participate in a clinical trial?
All clinical trials have
guidelines about who can participate. Using
inclusion/exclusion
criteria is an important principle of medical
research that helps to produce reliable results. The
factors that allow someone to participate in a clinical
trial are called "inclusion criteria" and those that
disallow someone from participating are called
"exclusion criteria". These criteria are based on such
factors as age, gender, the type and stage of a disease,
previous treatment history, and other medical
conditions. Before joining a clinical trial, a
participant must qualify for the study. Some research
studies seek participants with illnesses or conditions
to be studied in the clinical trial, while others need
healthy participants. It is important to note that
inclusion and exclusion criteria are not used to reject
people personally. Instead, the criteria are used to
identify appropriate participants and keep them safe.
The criteria help ensure that researchers will be able
to answer the questions they plan to study.
What
happens during a clinical trial?
The clinical trial
process depends on the kind of trial being conducted.
The clinical trial team can include doctors,
chiropractors, naturopaths, nutritionists, social
workers and other health care professionals. They check
the health of the participant at the beginning of the
trial, give specific instructions for participating in
the trial, monitor the participant carefully during the
trial following each companies specific set of
instructions.
Some clinical trials
involve more tests and visits than the participant would
normally have. For all types of trials, the participant
works with a research team. Clinical trial participation
is most successful when the
protocol is
carefully followed and there is frequent contact with
the research staff.
Risks
We do not take on
products for testing if there is any chance that our
test subjects could become ill or sick from the
products. We offer only non harmful and non toxic
products for testing.
What
is a protocol?
A protocol is a study
plan on which all clinical trials are based. The plan is
carefully designed to safeguard the health of the
participants as well as answer specific research
questions. A protocol describes what types of people may
participate in the trial; the schedule of tests,
procedures, medications, and dosages; and the length of
the study. While in a clinical trial, participants
following a protocol are seen regularly by the research
staff to monitor their health and to determine the
safety and effectiveness of their treatment. Sometimes
weekly or daily phone calls are made as to help maintain
strict protocol guidelines for our testing companies.
What
is a placebo?
A placebo is an inactive
pill, liquid, or powder that has no treatment value and
offers no measurable changes in our testing system. In
clinical trials, experimental treatments are often
compared with placebos to assess the experimental
treatment's effectiveness. In some studies, the
participants in the
control group
will receive a placebo instead of products or
experimental treatment.
What
is a control or control group?
A control is the standard
by which experimental observations are evaluated. In
many clinical trials, one group of patients will be
given an experimental drug or treatment, while the
control group is given either a standard treatment for
the illness or a placebo.
Clinical trials are conducted in phases. The trials at
each phase have a different purpose and help scientists
answer different questions: In
Phase I trials,
researchers test a experimental product or treatment in
a small group of people (20-80), usually for a 30-day
period, to evaluate its safety, determine the most
effective as well as safe dosage range, and identify
side effects. In
Phase II trials,
the experimental study products or treatment are
provided to a group of people (51-300), usually for a
6-month period, monitoring for new cellular changes in
the measurements of the subjects that may not have been
apparent in the Phase I trials and to further evaluate
its safety and effectiveness. In
Phase III trials,
the experimental study product or treatment is given to
large groups of people (100+) to confirm its
effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that
will allow the experimental product or treatment to be
used safely
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Fenestra
Research Labs © 2005
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