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FREQUENTLY ASKED
QUESTIONS
This page contains answers to common
questions frequently handled by our support
staff.
- What is a Clinical Trial ?
- What is a Clinical Trial Phase ?
- What is a placebo?
- What is Informed Consent ?
- What are the benefits of participation ?
- What happens when the trial ends ?
- What are the costs?
- Why participate?
- How can I Volunteer?
A research study in which a treatment or therapy is tested to see whether
it is safe and effective. Clinical trials are key to finding out which
treatments work. Clinical trials are a very important part of medical
research. Through clinical trials scientific discoveries can lead to
better ways to prevent, detect and treat medical conditions. Effective
therapies are applied to conventional health care.
Each clinical trail follows a protocol -- a written, detailed plan that
explains why there is a need for the study, what it is intended to do, and how
it will be conducted.
The Food and Drug Administration - FDA - has imposed mandatory safeguards
and regulations, which serve as guidelines for Clinical Trials. Doctors make a
commitment to follow all FDA guidelines to ensure a person's safety is not put
at risk. Clinical Trials are supervised by an Institutional Review Board
(IRB), an independent group of experts that monitor and insure that risks are
minimized, and worth the potential benefits.
Clinical Trials take place
in phases. In each phase different questions are satisfied.
 | PHASE ONE -- Primarily concerned with assessing the drug's safety.
The study is designed to determine what happens to the drug in the human
body-- how it is absorbed, metabolized, and excreted. A phase I study
will investigate side effects that occur as dosage levels are increased. |
| PHASE TWO -- Once a drug has been shown to be safe, it must be tested for
effectiveness and proper dosage. Most Phase II studies are randomized trials. One
group of patients will receive the experimental drug, while a second
"control" group will receive a standard treatment or placebo. |
| PHASE THREE -- In a Phase III study, a drug is tested in several hundred
to several thousand patients. This large-scale testing provides the
pharmaceutical company and the FDA with a more through understanding of the
drug's effectiveness, benefits, and the range of possible adverse
reactions. Most Phase III studies are randomized and blinded
trials. Once a phase III study is successfully
completed, a pharmaceutical company can request FDA approval for marketing
the drug. |
A placebo is designed to resemble the treatment being
studied in a clinical trial, except that the placebo is often inactive. By
giving one group of participants a placebo and the other group the active
treatment, the researchers can compare how the two groups respond and get a
better picture of the treatments effects.
Not all clinical trials compare an active treatment to a placebo. A
study drug is sometimes tested against a comparator-a currently used
medication.
Before entering a research study, it is important that you as the patient
fully understand the study and what your involvement would mean. ACT
staff members will help by providing you with an informed consent statement,
which has detailed information about the study, including the length of the
study, the number of visits that are required and medical procedures and
medication that will be included. It will also provide expected
outcomes, potential benefits, and possible side effects.
After you have the opportunity to review the informed consent statement,
you can ask questions of the ACT staff. If you decide to
participate, you will need to sign the informed consent statement. Your
signature indicates that you understand the study and agree to participate
voluntarily.
The participant may have a positive response to the therapy. Their
condition or disease may improve. Often the study medication is being
developed because it works differently than other drugs on the market,
providing an alternative treatment. Information that is collected from
clinical trials ultimately helps bring to the public new, safer, more
effective drugs. People who volunteer make the difference!
When a study is
complete, the FDA decides the future of the therapy. If results warrant,
the drug will go to market or on to further investigations.
Millions of people have benefited from Clinical Research thanks to the
thousands of people who have taken part as study subjects. The role of the
study subject as a partner in clinical research is crucial in the quest for
knowledge that will improve health care now, and in future generations.
Without the help of individuals like yourself these advances would not take
place.
Advanced Clinical Therapeutics does not charge for participation or
treatment in clinical research. In most circumstances, you may qualify for
travel and other expenses.
Funding for clinical research comes from both the federal government
(through the National Institutes of Health) and private industry
(pharmaceutical and biotech companies). The sponsor or the research
hires physicians, who may work in a wide variety of heath-care settings, to
conduct the clinical trial. Physicians are typically paid by the sponsor
of the study. The medical care is provided free to the
patient. Patients may also be paid a fee to participate in a clinical
trial.
If you are considering volunteering, please call 520-547-1800 to speak to
one of our Recruitment Specialists, who will enter you into our exclusive data
base.
 If you would like more information please email us your
daytime phone or call 520-547-1800
ActNow@AdvancedTherapies.com
SPONSORS CONTACT: WPatton@AdvancedTherapies.com
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