Is
a Clinical Trial Right for Me?
by Chris Thomas, TrialMatch.com
Patients take part in clinical trials for many reasons. While the
treatment that you receive may offer you the best outcome, it is
important to evaluate all of your options before you decide that a
clinical trial is right for you. Here are some things to consider:
Medical Criteria
It is important to understand the specific treatment being offered in
the trial and all of its potential risks and side effects, as well as
how if differs from the standard treatments being offered. You will also
want to know the eligibility criteria for the trial, so that you fully
understand why you might be accepted or excluded. Know, however, that
being accepted or excluded is determined by your general health match to
the particular criteria of the trial protocol.
Personal Criteria
It's important that you take many practical and emotional concerns into
consideration before participating in a clinical trial. You'll want to
find out how long the treatment can take what time commitment is
required, where
the trial will take place and whether travel will be required. For your
emotional well being, you want to know if you'll have to change
physicians and to what degree your family will be permitted to
participate. Keep in mind that often you will have to interact with
researchers and other additional healthcare personnel generating an
increased attention to all aspects of your health.
Insurance Concerns
It is important to consider that not all clinical trials are covered by
health insurance, or if they are, that all of the expenses may not be
covered. While the trial sponsors often provide the drug at no cost,
there are often many other costs associated with the trial, such as
travel to and from a medical center where the trial is located. Medicare
is now paying for clinical trials.
What Is Informed Consent?
Prior to enrollment in a study, a meeting with the patient and their
family to review the consent form and discuss any questions related to
the plan of treatment and side effects will take place. The
consent form is a written
summary of the study and the patient's signature is documentation of
agreement to participate in the study or treatment plan. According to
the Food and Drug Administration (FDA) informed consent is more than
just a
signature on a form, it is a process of information exchange. The FDA
further states that the entire informed consent process involves
providing a patient with adequate information concerning the study,
providing ample
opportunity for the patient to consider all options, responding to the
patients questions, ensuring that the patient has understood the
information, obtaining voluntary permission to participate and,
continuing to provide information to the patient as the situation
requires. The informed consent process is most effective when there is
an open exchange of information and questions between the patient and
expert.
Researchers want to find the patients and the patients want to find the
researchers; now that the internet can help researchers and patients
find each other. Currently, only about 3% of cancer patients get into
clinical trials. The feds recently ordered that Medicare begin paying
for treatment in clinical trails which should increase the number of
people in trials.
Clinical trials are not for everyone, but many more patients want
clinical trials, but don't know how to find out about them. Each
clinical trial is going to have very specific criteria for including
patients: you must have
a specific disease, in Stage X, had certain treatments, but not others,
etc. Matching the patients with the trials is the trick (see
below).
Recommended Books:
Celebrate Life : New Attitudes for Living With Chronic Illness by Kathleen Lewis
Chronic Illness and the Twelve Steps : A Practical Approach to Spiritual Resilience by Martha Cleveland
Travels With the Wolf : A Story of Chronic Illness by Melissa Anne Goldstein
©
2000 Chris Thomas
Chris Thomas is director of community for CancerPage.com, which sponsors the TrialMatch service.
TrialMatch.com may help visitors find clinical trials they may qualify
for. Trialmatch.com helps determine which trial you're actually
eligible for. Visit TrialMatch at http://www.trialmatch.com
for more information.
Copyright Notice: It
is illegal to reprint articles, in any format (including emails, web
sites, etc.), without explicit written permission from the author of
this article.
|
|