By Hilary Wright
In order to clarify any confusion, clinical
trials are often referred to in a number of
other terms by the members of the
medical-scientific community, such as clinical
study, research protocol, or medical research,
all meaning the same thing ... clinical trial.
The National Cancer Institute (NCI) defines a
cancer clinical trial as "an organized study
conducted in people with cancer to answer
specific questions about a new treatment or a
new way of using an old treatment." The process
of finding out about an appropriate clinical
trial for a loved one usually begins by
discussing the possibility with their oncologist
(cancer specialist). Once you and your
loved one have decided upon a particular
clinical trial, and feel it could prove
beneficial, a few more factors must be
considered which may still affect whether your
loved one will want to participate or not.
Every clinical trial has its own guidelines for
who is eligible to be a part of the study.
Generally, participants are alike in several
ways, either having in common the same type and
stage of cancer, age, gender, or previous
treatments. Eligibility criteria are generally
included in the study plan, and you can find out
if your loved one is eligible for a particular
study by talking to their doctor or to the
doctor or nurse in charge of enrolling patients
in the study. Cancer clinical trials may consist
of a little bit of everything, and can be found
to exist in different formats, like:
Treatment trials: where new treatments for
cancers are tested, including new drugs, new
approaches in surgery or radiation therapy, or a
new combination of treatments or methods, such
as gene therapy or immune therapy.
Prevention trials: tests new medicines,
vitamins, minerals, or
other supplements which may lower the risk of
certain types of cancer. These trials look for
ways to either prevent cancer in people who have
never had it, to prevent cancer from coming
back, or prevent a new form of cancer from
occurring in people who already have cancer.
Screening trials: this tests for the best ways
to find cancer, especially in its’ earliest
stages.
Quality of Life trials: also called Supportive
Care trials, ways are explored to improve
comfort and quality of life for cancer patients.
It must be understood that if your loved one is
found to be eligible for a clinical trial that
is for a new cancer drug, the clinical research
will involve a series of steps referred to as
“phases” in order to test the new drug. These
phases allow researchers to ask and answer
questions that will result in reliable
information about the drug, as well as
protection for your loved from any possible
problems. Clinical trials are usually classified
into one of three phases:Phase I trials: These
are the first studies in which people are
evaluated on how a new drug should best be
administered (by mouth, injected into the blood,
or injected into the muscle), how often, and
what dose is considered to be safe. Usually only
a small number of patients are enrolled in this
phase, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to
test the safety of a drug, and begins to
evaluate how well the new drug works. Phase II
studies usually focus on a particular type of
cancer.
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