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Understanding Research Opportunities...
Is Participating in a Clinical
Trial Right for YOU?
People who have been diagnosed with cancer quickly learn that there
is a wealth of information “out there” about the many forms of this disease.
The trick is to learn how to process that information and then how to make
the best use of it.
The media carries stories every day announcing that researchers have
found a new treatment for this kind of cancer, or a “cure” for that kind.
Unfortunately, the lead time between a promising laboratory experiment
and a proven treatment available for use with any appropriate patient can
be years.
Before any new treatment is declared safe and effective, specialized
research, referred to as clinical trials, is conducted in compliance with
complex and exhaustive criteria. While the specific process for these
trials may vary country to country, clinical trials are precisely regulated
and the general principles are always the same.
Any patient considering participating in a clinical trial should understand
exactly what is involved before making a commitment. Individual trials
are designed to seek specific information. Some trials, for example,
are not intended to find out if a particular drug or therapy can cure a
specific kind of cancer; but only to discover if that drug or therapy is
even worth examining further as a possible treatment.
Clinical trials, like most fields in medicine, have their own language.
There is no handy patient “dictionary” for this language, so here are a
few terms that will help patients get in the discussion.
Phase I: Phase I trials are
designed to find out if a drug can be safely given to humans and, if so,
what is the highest dosage patients can tolerate. These trials are
usually carried out in a small patient population, with perhaps only 10-20
people.
Phase II: This phase of the
research determines if patients can be helped by the tolerable doses of
the drug in the treatment of a specific disease. This level is also
done with a small patient population.
Phase III: These are the larger
trials involving thousands of people at many institutions. They are
designed to prove that a specific type of therapy is as good or better
than some standard form of therapy. They may involve new drugs or
compare the impacts of differing types of radiotherapy or surgical
treatment.
Double Blind: a method for conducting clinical trials that prevents
both patients or researchers who carry out the actual treatment from knowing
which patients are receiving the product being tested, or a comparison
product, which may be a placebo.
Placebo: this is normally an inactive substitute drug packaged to look
exactly like the active drug being tested, used in a trial which looks
for a significant benefit from the active drug over the placebo.
Multi-center: trials in which more than one health or research center
enroll patients in a specific trial according to a common protocol.
Protocol: this is the exact research plan, which cannot vary, by which
all the investigators agree to diagnose, treat, and evaluate the patients
enrolled in the trial.
Randomized: distributing different therapies in a clinical trial so
that each patient entering the trial has a preset chance of receiving any
one of the therapeutic options being tested against each other. This is
predetermined blindly and could be accomplished, for example, by choosing
odd/even numbers, selecting every other patient, or even drawing names
from a hat.
There are obviously many factors to be weighed before deciding whether
or not to apply for participation in a clinical trial. Above all,
it is critical that patients understand exactly what is involved in the
trial before they decide to enroll.
INFORMED CONSENT...
In any clinical trial which has formal FDA approval, potential participants
are given extensive information before they are asked to give their “informed
consent.” This information is often contained in a multi-page, consumer
language document which addresses what the study will involve -- step by
step.
It will state the specific goals of the trial, and cover the details
of any procedures to be performed, medications to be taken, tests to be
done, the length of time involved as well as information about any risks
and potential discomfort associated with the study.
Remember, participation in a clinical trial is entirely voluntary.
There are no promises that the treatment being studies will be helpful
in your individual case. Read all information carefully and don’t
hesitate to ask questions before reaching a decision. |
