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Frequently Asked Questions About Clinical Trials
Questions
and concerns are a natural part of investigational drug studies
and clinical and medical research. This sections tries to answer some of these
questions for both patients and sponsors of clinical trials. If this
section doesn't address your question use our feedback
form to get a quick response.
PATIENT
QUESTIONS
What are clinical trials?
- Clinical
trials are controlled evaluations of new therapies. Controlled
clinical trials were first suggested in the 1930's by the British
statistician Austin Bradford Hill. Their use spread slowly in
the 1950's. More than 41,000 clinical trials are now underway
around the world.
They are usually organized into four phases: Phase I, Phase II,
Phase III and Phase IV. After an investigational drug has passed
numerous animal and laboratory tests for safety and beneficial
effect, the drug enters phase I. In phase I the drug is given
to normal volunteers to test its safety in people. If the drug
proves safe in normal people it is given in different doses to
people with the disease of interest. This is phase II. Once the
most effective dose has been identified the drug enters phase
III. In phase III it is given to large numbers of people (generally
more than 1000) to see if it is truly effective and safe in treating
a specific disease. Once the drug successfully passes phase III,
it will usually be approved by the FDA for use by all physicians
in treating that disease. Phase IV trials usually are conducted
for marketing purposes after the drug has been approved by the
FDA.
What
is a placebo?
- A placebo
is an inert substance, such as a sugar pill, that is expected
to have no effect on the patient. It looks just like the active
drug. In drug studies the investigational medication will be tested
against the standard therapy or a placebo to verify if the investigational
medicine had any effect.
What
does double blind and single blind mean?
- A double
blind drug study means both the investigator and the patient do
not know if the patient is taking either the investigational medicine
or the standard treatment/placebo. In single blind clinical trials
the investigator will know which therapy the patients are taking.
What
is informed consent?
- Informed
consent is a document used to "inform" the participating
patients to various aspect of a study. The document will explain
the purpose of the study, the drugs being studied, and visits
required of the patients. It will also describe the potential
risks or side effects as well as the potential benefits of participating
in the study. Most clinical trials involve participants with competent
mental ability that can understand the document. It is the first
step to any clinical trial and is signed by the investigator (doctor),
the patient, and a witness.
What
will it cost me to participate?
- You will
incur no cost from participating. In addition, a small stipend
is usually paid to you for participation.
Where
is C.A.R.E. Clinical Research?
- The office
is located at 533 Couch Ave, Suite 140, adjacent to St. Joseph's
Hospital in Kirkwood. It is staffed by trained physicians and
nurses. Dr. Hyers is board-certified in internal medicine, pulmonary
medicine, and virtual care medicine. He has had fifteen years
experience in supervising phase III clinical research.
Will
I always receive the new drug being tested?
- Not always.
In some studies you may receive the current best drug for comparison
with the new drug. In other cases where there is no proven treatment,
you may receive a placebo. Which group you fall into is chosen
randomly by a computer. This process is called "randomization."
In either case you will receive careful and attentive medical
monitoring.
Will
my doctor know about my care?
- Yes. Your
doctor will be kept informed. When the study is completed, you
and your doctor will receive a summary of the results.
Read
about clinical trials offered
at this site.
CRO
AND SPONSOR QUESTIONS
Investigators
- Thomas M.
Hyers, M.D. Dr. Hyers is clinical professor of medicine at St.
Louis University School of Medicine and has conducted high quality
clinical research for over fifteen years. He is an internationally
recognized educator.
- Joseph Ojile,
M.D. Dr. Ojile maintains a large private practice in pulmonary
diseases and has conducted clinical research for over seven years.
Study
Coordinators
- Experienced
study coordinators completing projects in multiple therapeutic
areas. Remote Data Entry as well as paper C.R.F. projects completed
for sponsors and CRO's..
PFT
Technician
- Fully trained
PFT technicians for on-site performance of pulmonary function
tests.
Special
capabilities
- Spirometry
- Full PFT's
- Dosimetry
and Bronchial Challenge
- Exercise
Testing
- EKG
- Dyspnea and
Performance Questionnaire Experience
- Full Day
Testing Capability
- Directly
adjacent to hospital laboratory support
- Completed
studies for sponsors in areas of emphysema, chronic bronchitis,
asthma, hypertension, the common cold, pneumonia, deep venous
thrombosis, pulmonary embolism and allergic rhinitis
Study
Site
- The site
is a fully equipped office of 2500 square feet adjacent to St.
Joseph's Hospital in west St. Louis Country. The site is easily
accessible to a large suburban study population
Sponsors please contact us for more
information.
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