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As a research
volunteer, you may receive free
medication and free medical care for
the condition being treated. Many
studies pay for many diagnostic
procedures like ECGs, x-rays,
mammograms, and BMD's . You may also
be compensated for your time and
travel.
As you participate, you will have a
chance to talk with health care
professionals about your medical
condition. In many cases, they can
provide you with counseling on
issues like diet and exercise,
preventative therapies, etc. But,
most importantly, you will have the
satisfaction of knowing that your
participation may help medical
professionals to better understand
and treat disease.
Clinical Research: ...is it right for
me?
What is Clinical Research?
Before a new drug is
sold, the Food and Drug Administration (FDA)
must be absolutely certain that it is both
safe and effective. In order to be sure, a
drug must pass through several phases of
testing. Most involve giving the drug to
research volunteers under the watchful eye
of a physician investigator.
History of Clinical Research
Before the early
twentieth century, drugs sold in the U.S.
were not regulated. Anyone could create a
concoction and proclaim that it would cure
anything from colds to cancer.
In 1906 the Foods and Drugs Act established
that drugs must meet standards of strength
and purity. A poisonous and untested drug
that caused the tragic death of 107 people
prompted the government to create the
Federal Food, Drug and Cosmetic Act in 1938.
This law required manufacturers to prove
safety before a drug could be sold.
In 1951, the Durham-Humphrey Amendment
defined prescription drugs as those that
must be taken under a doctor's supervision.
Another tragedy occurred in 1962 that
further defined the clinical research
process. In western Europe, thousands of
babies with birth defects were born to
mothers who had been taking a sedative,
thalidomide. The Kefauver-Harris Amendment
required the following:
Preclinical and purity data must be
collected Effectiveness must be proven by at least 2
controlled research studies Informed consent must be obtained from
volunteers participating in a research study
Today, clinical research is conducted only
by qualified physicians and is closely
monitored by the FDA and independent review
boards that work hard to protect the
research volunteers.
Even after a drug is approved for sale, it
is carefully monitored by the manufacturer
to make sure that it is always safe and
effective.
What is a Research Volunteer?
Before any research study
can begin, patients or research volunteers
must be identified who meet certain
inclusion criteria. In other words, these
patients must have the condition that is
being treated. Exclusion criteria are
conditions that must not be present. If
these conditions are present, it might not
be safe for them to participate in the study
or it might make it difficult for the
investigator to judge if the study
medication is helping them.
Participation in a research study is
voluntary! A research volunteer may withdraw
from the study at any time. The
physician/investigator may also withdraw a
volunteer from a study if he/she feels it is
in the patient's best interest.
As a research volunteer, you are expected to
follow the study instructions very carefully
and to attend all scheduled clinic visits.
You may be asked to keep records of the
medicine you take and report any changes in
your health.
What are the Benefits of
Being a Research Volunteer?
As a
research volunteer, you may receive free
medication and free medical care for the
condition being treated. Many studies
pay for many diagnostic procedures like
ECGs and X-Rays. You may also be
compensated for your time and travel.
As you participate, you will have a
chance to talk with health care
professionals about your medical
condition. In many cases, they can
provide you with counseling on issues
like diet and exercise, preventative
therapies, etc.
But,
most importantly, you will have the
satisfaction of knowing that your
participation may help medical
professionals to better understand and
treat disease.
How Do I Become A Study
Volunteer
To
begin the process of becoming a study
volunteer, please
click here for our demographic questionnaire.
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Copyright [2005] [Physicians Research Group]. All rights reserved |
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