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Considering a Clinical Trial?
Answers to basic questions about trial types, benefits and opportunities
to participate
While joining a clinical trial may not be a fitting choice for
everyone, experts fear that too few cancer patients are even aware
of the option. Less than 5% of cancer patients participate in clinical
trials and, perhaps more tellingly, over 85% of patients in one
poll said they did not know clinical trials were even available
to them. What’s more, certain populations - racial and ethnic
minorities, women, the elderly - are underrepresented in clinical
trials, a deficit that could impact treatment in those populations.
If you have cancer, you owe it to yourself at least to put clinical
trial participation "on your radar" in terms of possible
treatment approaches.
What are clinical trials?
Clinical trials are medical research studies conducted with patients
who volunteer to participate. (Preclinical trials study experimental
treatments in test tubes or in animals; these trials must be done
before human studies may be conducted.)
What are the types of clinical trials?
Although news stories often focus on trials of cancer treatments,
there are also clinical trials that address prevention, diagnosis
and other important aspects of cancer care.
Treatment trials are designed to evaluate new
treatments - which can include drugs, surgical techniques, radiation
therapies - or combinations of therapies. Treatment trials are conducted
with people who have cancer. There are several distinct phases of
trials (see below) through which treatments must progress in order
to be approved for general use.
Prevention trials study ways of reducing cancer
risk. Some prevention trials involve healthy people who've never
had cancer. Others studies, involving people who have had cancer,
look at ways to prevent the cancer from returning or prevent a new
type of cancer from developing.
Diagnostic trials assess tools and methods for
identifying cancer more accurately and at earlier stages. These
trials usually involve people who have cancer symptoms. In contrast,
screening trials often test similar tools and methods, but usually
with people who do not have any cancer symptoms.
Quality-of-life (or supportive care) trials assess
ways to improve the comfort and well-being of cancer patients and
cancer survivors. For example, these studies might address treatment
side effects (e.g., nausea, vomiting, sleep disorders) or other
problems caused by the cancer or its treatments.
What happens during the different phases of clinical trials?
New treatments must go through a series of clinical trial stages
before they can be eligible for approval by the Food and Drug Administration
(FDA). If the results of one trial phase are acceptable, the treatment
can advance to the next phase.
Phase I trials are designed to determine a treatment's
safety, side effects, dosage and administration method (e.g., by
mouth, by injection). Phase I trials usually enroll just small numbers
of people.
Phase II trials measure the treatment's safety and effectiveness
against a specific type of cancer. These trials may have more participants
than Phase I trials, but usually fewer than 100.
Phase III trials compare the new treatment to the standard
treatment for a given type of cancer. Phase III trials often involve
hundreds of patients at different hospitals and medical practices
nationwide. In most cases, trial results are submitted for FDA review/approval
after the Phase III trials.
Some treatments continue into Phase IV trials after FDA approval.
These studies assess the treatment's long-term safety and effectiveness,
and may involve hundreds or even thousands of participants.
What are the benefits and risks of participating in a clinical
trial?
The "pros" and "cons" of joining a clinical
trial vary from study to study, and from patient to patient. In
deciding on a clinical trial, here are some factors you may wish
to consider:
Potential benefits
Having access to a promising new treatment before it is available
on the market
Benefiting from a treatment that may be better than standard available
treatments
Thorough, high-quality medical attention from trial doctors and
healthcare team
Free trial medicines and/or medical care, depending on the trial
The choice to leave the trial at any point, if desired
Opportunity to contribute to efforts that may help others in the
future
The majority of participants in cancer clinical trials are white males, by participating in clinical trials, minority and other medically underserved people can help ensure that new treatments are studied and used appropriately in their communities.
Potential risks
A new treatment that may not work for you, or that may be less effective
than current standard treatments
Unexpected side effects either during or after the trial
Expenses that are not covered by the trial sponsor or health insurance.
How does participating in a trial affect the role of my regular
doctor?
In general, the care one receives through the trial doctors is in
addition to routine care by the primary care physician, oncologist
or other treating doctor. The trial doctor and team should provide
status reports and updates to the treating doctor. If routine tests
(imaging scans, lab tests, etc.) are done as part of the trial,
results should go to the treating doctor so the tests are not duplicated
unnecessarily.
It is important to realize that very stringent criteria are used
to implement and monitor clinical trials. Included in the monitoring
process is the informed consent process. All human subjects that
enter into clinical trials must receive informed consent that has
been approved by the Universities IRB (Institutional Review Board)
that determines whether or not the trial is safe for human subjects
and whether or not the risks of the trial justify the potential
gains. For example if the trial is intended for a disease that has
no existing cure and is fatal a greater level of risk might be acceptable.
How can I find out about clinical trials that might
interest me?
A good way to start is by expressing interest to your regular doctor.
He or she may already know of trials enrolling in your geographic
area.
There are also several key sources that provide up-to-date information
on clinical trials and opportunities to enroll:
Cancer-specific trials
(National Cancer Institute)
Cancer Information Service
Toll free: 1-800-4-CANCER(1-800-422-6237)
TTY (for deaf/hard-of-hearing callers): 1-800-332-8615
Clinical trials listings (include cancer trials)
www.ClinicalTrials.gov
www.CenterWatch.com
New Jersey Clinical Trial Connect
Additional Resources
Coalition of National Cancer Cooperative Groups. Myths and facts
about cancer clinical trials.
Medical Study News.
Racial and ethnic minorities, women, and the elderly were less likely
to enroll in cancer clinical trials than whites, men, and younger
patients.
National Cancer Institute
National Institutes of Health
Translational Research
National Center
for Human Genome Research - the National Institutes of Health's
site detailing the latest research into gene therapy and the identification
of those genes that may cause cancer.
American Association
for Cancer Research - AACR is a scientific society of over 17,000
laboratory and clinical cancer researchers that facilitates communication
and dissemination of knowledge among scientists and others dedicated
to the cancer problem. In addition, as part of their annual conventions,
AACR sponsors Public Forums as an outreach to the general community
to provide information on the latest developments in cancer research
and to encourage a dialogue between scientists and the public
Department of
Defense - information on the latest research studies approved
under the Congressionally Directed Medical Research Program.
National Human
Genome Research Institute - understanding how the interaction
of genes can activate, accelerate or destroy cancers
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