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About ECHO Clinical Trials
 In the last few decades, important progress
has been made in cancer diagnosis and treatment modalities, with
improvement in the overall survival and quality of life of patients
with cancer. However, sometimes the best available treatments
may be less than satisfactory in most of the malignancies. Identifying
new, effective treatments can be done only through clinical research.
It is through this science that exciting new ways to treat cancer
are being discovered, providing a better quality of life for
our patients.
There are thousands of people who have benefited from clinical
trials. Over the years many of the drugs that were tested are
now considered standard treatment for cancer patients all over
the world.
Research treatments offered by ECHO are reviewed at a number
of levels nationally and/or locally, to ensure both the protection
of patients’ rights and the scientific merit of the research.
The Institutional Review Board (IRB) is an independent body constituted
of medical, scientific and non-scientific members, whose responsibility
it is to ensure the protection of the patients rights and safety.
The IRB assures the well-being of patients involved in every
new trial by reviewing, approving and providing continuing review
of trials, protocols and amendments and of the methods and material
to be used in obtaining and documenting informed consent of the
trial participants. The review process assures the trial is safe
and beneficial to its participants and the medical community.
The staff at ECHO Associates is very committed to being forerunners
in research and clinical trials for Oncology and Hematology related
conditions. ECHO Associates offers patients the possibility to
participate in clinical trials, an option sometimes available
only in academic centers. The staff at ECHO Associates has shown
their commitment to being in the forefront by participating in
many clinical trials, as a part of large cooperative oncology
groups (ECOG, NSABP and ACORN) or industry sponsored trials.
What is a Clinical Trial?
A clinical trial involves taking a new drug or therapy from the
laboratory, testing its efficiency and safety prior to it being
approved by the Food and Drug Administration (FDA). Clinical
trials help ascertain if new treatments are a safe and effective
way to treat patients. During trials, important information is
gathered about the new treatment, the risks and how effective
the drug may be.
Before a drug is approved for use, it goes through various stages:
A cancer drug is initially discovered in the laboratory. It is
then tested on laboratory animals and specific cancer cell lines.
Once it appears that a particular drug may be effective in inhibiting
growth, then it enters the clinical phase of development.
A Phase I clinical trial is the first step in determining if
a newly discovered drug is safe for patient use. It is during
this phase that it is determined how the drug would be best administered,
if there are any harmful side effects and what would be the safest
dose to use.
During Phase II trials, doctors test to find the effectiveness
of the new drug on specific cancers with the goal that the new
drug would improve on the present available treatments.
By the time it reaches a Phase III clinical
trial, the effectiveness and safety of the new drug has already
been tested. In this phase,
doctors compare the new treatment to the standard treatment.
This is accomplished through a randomized study. A study includes
two separate groups:
- The Intervention Group- those who are given
the new treatment
- The Control Group - this group receive either the standard
treatment or a placebo (a treatment that contains no active
ingredient).
Phase
IV, is the post marketing phase of a trial. After the drug
is approved by the FDA and is available on the market,
it can
be further studied for better ways of administrating it.
Other clinical research studies address the management of
chemotherapy-induced side effects and cancer symptoms that
continue to be inadequately
treated in cancer patients, with significant impact on their
quality of life.
Clinical trials are required to follow very strict guidelines.
Each clinical trial is overseen by a chief investigator,
usually a doctor, who develops a protocol for the new medicine.
Each
protocol has specific criteria for who may participate, how
many patients will participate in the study, how the drug
will be
administered and how the information regarding the results
will be gathered. Every center participating in a trial follows
the
same protocol, insuring that all the information gathered
will be true and accurate.
At Eastern Connecticut Hematology and Oncology patients are
offered participation in Phase II, Phase
III and Phase IV clinical studies.
Other trials run at ECHO include quality of life and prevention
trials that study ways of reducing the risk of getting cancer,
particularly in persons at high risk. These trials imply
either taking a certain medication, (such as hormonal medication
or
vitamins) or by modifying their lifestyle (for example: smoking
cessation).
ECHO Associates is a part of an unique quality improvement
program (AIM higher Initiative) launched in 15 community
oncology practices
in the US. It uses a pen-based computer technology designed
to facilitate assessment of symptoms and provides access
to scientific
and clinical information regarding symptoms.
While some people have very positive results, there are risks
and side effects that need to be taken into consideration.
Only you, along with your doctor and family, can decide if
you should
participate. If you are interested in exploring the possibilities
of a clinical trial, please make an appointment with one
of the ECHO Associates Oncologists. They will be happy to
answer
any
questions you may have regarding current or upcoming trials.
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