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Q: What is a Clinical Study?
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Q: Why should I participate?
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Q: What can I expect?
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Q: What happens after the trial?
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Q: How do I participate?
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Q: What studies are currently available?
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Answer
What is a
Clinical Study?
A clinical trial is a carefully designed study
that is done with people like you who volunteer to receive
investigational treatments under close supervision by a physician
and other research professionals. Pharmaceutical and biotechnology
companies have developed these treatments. And these companies have
then selected physicians, also called investigators, who are
qualified to conduct clinical trials. It is through these trials
that investigational drugs may show their benefits.
The clinical testing of an investigational drug
is a step-by-step process that ensures you receive careful medical
attention. All clinical trials are reviewed by the U.S.
government's Food and Drug Administration (FDA) and of Institutional
Review Boards (IRBs).
IRBs are independent committees whose job is to
make sure your rights are fully protected and that you are not
exposed to any unnecessary risks. IRBs also are responsible for
ensuring you sign a consent form before agreeing to participate in a
trial.
Clinical trials usually are conducted in three
phases (I, II, III). A small number of people participate in Phase
I trials. Each later phase involves a larger number of people.
In a clinical trial, a volunteer is usually
assigned a specific study group. Sometimes volunteers in one study
group will receive an investigational treatment or study drug.
Sometimes volunteers will receive a placebo or a treatment already
available.
A placebo is an inactive product used to
compare the results of the study drug. You, your physician and your
research staff may not know who is receiving a placebo and who is
not. In this way, volunteers in a clinical trial can be observed by
the physician and research staff more fairly. Whether you receive
the placebo or the investigational drug, the level of medical
attention and care that you receive is the same.
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Why
should I participate?
As a volunteer in a clinical trial, you help in
the development of medical therapies--therapies that may offer
better treatments and even cures for life-threatening and chronic
diseases.
People volunteer to participate in a clinical
trial for a number of reasons. You may get involved in a trial
because you simply want to help in the advancement of science. Or
you may be suffering from a disease for which a good treatment does
not exist presently. You may join a clinical trial hoping to get
improved medical care. Or you may not have health insurance and
clinical trials are a way to get study-related medical care.
Whatever reason you choose, you may have
questions about clinical trials and drug research. This website
answers some of your questions. You should also ask your physician
and our research center's staff any questions before you volunteer.
It's important that you make an informed choice
about volunteering for a clinical trial.
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What can I expect?
Once you have enrolled in a study, you may
receive a physical examination. Your study physician or a research
staff member will review your medical history as well. A detailed
description of your specific clinical trial and what's expected of
you will be outlined in your consent form.
Physicians and healthcare professionals that
conduct clinical trials are committed to providing you with quality
patient care and medical attention. You should feel free to discuss
your medical treatment with your investigator or any research staff
member at any time during the course of your clinical trial.
Your safety is the number one priority in a
clinical trial. Therefore, it's important that you take all your
medication as prescribed, that you keep all of your scheduled
visits, and that you answer your investigator's questions regarding
how you feel and whether you've been taking your medication at the
scheduled times.
Many study volunteers appreciate the medical
attention that they receive when they participate. Your study
investigator needs to record any symptoms no matter how minor they
may seem to you. If you miss your medication or you haven't taken
it on schedule, tell your physician or research staff. Your input
is valuable and important.
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.
As a volunteer, you have the right to leave
your study at any time, and for any reason.
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What
happens after the trial?
When a clinical trial ends, several things
might happen. For a serious illness, a pharmaceutical company might
continue to provide the study medication to those patients that are
responding well. On some occasions, a patient will stop receiving
the investigational treatment. In this case, a patient may have to
wait for the drug to become available to the public.
After a study is complete, all of the
information is collected and analyzed. This information determines
whether a study drug is working, whether it is safe and whether it
has any side effects. FDA medical advisors and specialists closely
review this data before approving any new drug.
Even after a drug is approved, pharmaceutical
companies will continue to conduct studies that compare the new
drug-in terms of its safety, effectiveness and cost-to other drugs
already on the market. Other research studies may determine if a
therapy can be administered to children or special populations. And
some studies assess a drug's long-term effectiveness and its impact
on the quality of a person's life.
Every volunteer in a clinical trial is
extremely valuable and important. Without volunteers, there would
be no new drugs to fight diseases and ailments. By participating in
a clinical trial, you are helping yourself and others like you live
longer and healthier lives now and long into the future.
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How do I
participate?
To participate, please contact us by phone at
(505) 244-7407 to schedule a screening to find out if you qualify to
enroll in one of our exciting new studies. Many studies offer
stipends to qualified patients as well as study treatment at no
cost.
Contact Us
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What studies are currently available?
Please see our
Current Studies page for full details on current and upcoming
studies.
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Please note:
All study patients receive at no cost: Physical
assessments, Laboratory tests, Patient education, Diet counseling,
X-rays, and medication. All results will be shared with the
patients’ Personal Care Provider upon request. Stipends are usually
based on the number of visits and paid upon successful completion of
the study.
717 Encino Place NE • Suite 24 Telephone
(505) 224-7407
Fax (505) 224-7404
Watch for DENTAL studies coming soon to
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