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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.

Genetics studies look at how genes may affect the development of cancer or patients’ response to treatment. Genetic studies are frequently part of another type of clinical trial. Depending on the study, participants may or may not have cancer.

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

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. (Before joining a trial, talk in detail about this with the trial team and your health insurer.)
Why should members of minority groups consider joining cancer clinical trials.

The majority of participants in cancer clinical trials are white males, while certain populations - racial and ethnic minorities, women and the elderly - are underrepresented. It makes sense that if a new treatment will be used in a diverse population once it's on the market, it should also be tested in a group that reflects that diversity. Furthermore, scientists are finding that factors such as age, geography, gender and genetics account for differences in response to the same treatment. In the words of oncologist Alex A. Adjei, MD, PhD: diversity in clinical trials is not a matter of "racial quotas....this is not affirmative action - it is good science."

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.

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.

Before joining a clinical trial, it is important to discuss it in detail with one's treating doctor.

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

 

 

 

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