| Research
- Question / Answer
 What
are Clinical Trials?
Why should
I participate in a clinical trial?
How are clinical
trials organized?
Who is eligible
for clinical trials?
Are such studies
safe?
How do i enroll?
Will my doctor
get upset if I choose not to go into a trial?
Who pays?
Past Studies
Current Open Studies
Contact Information and Other Links
 What
are Clinical Trials?
Clinical trials evaluate various treatment
methods which in turn help in the fight to decrease death or injury
from various medical conditions. If a new treatment proves helpful
in a study, it may become a new "standard treatment" that
can be used with all patients. Some of today's most important standard
treatments came from prior clinical studies. Clinical trials are
designed to investigate various scientific questions with these
answers leading to further research or treatment recommendations.
The progress
made through clinical trials in treating various medical conditions
means people may live longer, healthier and happier lives.
These are studies of various medical problems that rely on volunteers to test
new ways of treating, testing, or preventing a disease. They usually develop
from studies in the laboratory or with animals that have shown promising results
in the treatment of particular diseases. A clinical trial is designed to answer
very specific questions concerning new therapies in the treatment of a disease.
They are guided by a protocol which is a step by step guide for the nurse and
physician to follow in treating, evaluating and following the condition to make
sure the treatment is working .
back to top
Why
should I participate in a clinical trial?
The patients who participate in clinical trials get the most up to date care
from physicians that are working in conjunction with nationally and internationally
known physicians. These experts are passing on knowledge to the providers
of Olive Branch Family Medical who are then improving the care of their individual
patients (both those in studies as well as those not participating). These
patients typically receive either a new treatment being tested or the best
existing standard treatment for their problem being studied. When new treatments
prove effective or better than standard treatment, study patients who get
it may be the first to benefit.
How
are clinical trials organized?
All drugs go through several phases of development before they are
released for general use by the public.
Phase 1 trials focus on the safety of the drug, including
how it should be given and at what dose. The patients will be monitored
for side effects and
how the drug is removed from the body over time. Usually this is with healthy
volunteers and generally few in number.
Phase 2 studies focus on the safety and treatment effectiveness.
The physician will monitor the patient for side effects and how well the
medical condition
responds to the study drug.
Phase 3 studies compare current treatment versus new approach
or drug. New treatments may include new medications, new dosages, or new
combinations of
medications. Patients are randomly assigned to receive the experimental
treatment or the current therapy.
Phase 4 studies gather more specific information on drugs that have already
been approved by the FDA.
The Research Department of Olive Branch Family Medical conducts some Phase
2 studies but mostly Phase 3 and 4 studies.
back to top
Who
is eligible for clinical trials?
Each study has very specific criteria for who can or cannot be included.
People who are possibly harmed by study drugs are not allowed to enroll.
To be able
to participate all of the inclusion criteria must be met and NONE of
the exclusion criteria can be met. These are reviewed by nursing personnel.,
then by the
physician, then by an individual tasked to monitor every study site and
patient.
Are
such studies safe?
The FDA oversees all research involving humans. The agency weighs
the potential risks and benefits of each study and determines what
things
should be evaluated
more thoroughly. Every study is reviewed by an IRB (Institutional Review
Board) which has the task of making sure the study does not put the
patient at risk,
has a potential benefit, and has requirements for closely monitoring
the patient through exams and laboratory studies. The IRB includes
people
from the community
such as clergy, health professionals, and consumers. Volunteers receive
written information explaining the study, the benefits, the risks,
and the patient's
rights. Patients may drop out of a study at any given time.
back to top
How
do I enroll?
After you and your health care provider have determined that you
are eligible for a clinical trial, a nurse will explain the study
to you.
She will inform
you of the purpose of the study, the procedures involved, how long
the trial will last, and benefits or risks to you. She will ask
you to
sign a document
saying all of this has been discussed with you---- this is called
informed consent. It is NOT a contract and you CAN quit the study
at any time.
Will
my doctor get upset with me if I do not go into a clinical trial?
Your health care provider is primarily interested in your health.
His/Her participation in clinical trials is just another way
for them to obtain
the most comprehensive
and up to date medical knowledge concerning your medical disease
and to offer you the option of participating in this "cutting
edge" medical
therapy. That is why they spend a lot of time explaining the studies
to you and letting
you make the final decision. No matter whether you participate
or not in the study, he or she is doing their best to improve
your health .
back to top
Who
Pays?
The study's sponsor covers the costs of the medications being
evaluated in the study, the office visits associated with the
study, and
the lab work monitoring
the study.
back to top
Medical Conditions that have been studied in the past.
Hypertension, Diabetes, Hormone Replacement, Birth Control,
Migraine Headaches, Irritable Bowel Syndrome, Gout, Arthritis,
Sinusitis,
Bronchitis, Premature
Ejaculation.
Trials
that are currently open for patients to be able to enroll in
• Diabetes
• High Blood Pressure
• High Cholesterol
• Atrial Fibrillation
• Fibromyalgia
• Overactive Bladder
• Diabetic Neuropathy
• Past Herpatic Neuropathy
• Shingles
Contact information
If interested in participating in one of clinical trials
or if have medical condition would like for us to try
to get study
started in call 662.895.4949.
More Information About Clinical trials...
www.clinicaltrials.gov
Family Practice Information
www.familydoctor.org
Information about research participation
www.ciscrp.org
back to top
|
