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Clinical Trials

There are new discoveries in cancer research every day. Translating scientific discoveries into improved cancer care for people requires testing through the clinical trials process. Clinical trials are research studies testing new prevention and treatment methods to determine whether they are effective and safe, and better than the best-known treatment
or current standard of care. Deciding whether to participate in a clinical trial can be a very difficult decision.

As treatments are untested, the outcomes are unpredictable. That means that some people may benefit from participating and some people may expose themselves to risks. (See the section Understanding the Risks and Rewards below.) This is a highly personal choice without a right or wrong answer. Learning as much as you can about clinical trials in general is a good place to start.

Challenge: How do I know if a clinical trial is right for me?

Sollution: The only way to know if a certain clinical trial is right for you is to discuss it with your doctor. Only your doctor knows your medical history and can determine if a clinical trial is a viable treatment option.

How Clinical Trials are Set Up
All clinical trials have guidelines about who can participate. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. Eligibility criteria for clinical trials include a person’s age, gender, medical history and current health status and often require that patients have a particular type and stage of cancer. Each trial follows a protocol or set of rules. A protocol is a kind of “action plan” for the clinical trial. The plan will describe the schedule of tests, procedures, medications and doses as well as the length of the study. Participants will receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean a person must stay in the study. A participant can leave the study at any time, either before the study starts or at any time during the study or the follow-up period.

While in a clinical trial, participants are seen regularly by the research staff to monitor their health and determine the safety and effectiveness of the treatment. The research team consists of doctors, nurses, social workers and other healthcare professionals.

Phases of Clinical Trials

Phase I: Is the Treatment Safe?
While these treatments have been well-tested in the laboratory and on animals, their impact on humans at this stage is unknown. Phase I tests to see if a treatment is safe for humans and to determine the dosage of any medications.

Phase II: Does it Work?
Once a treatment is deemed safe for use by humans, the next step is to see whether the treatment works against cancer. Researchers look for a response: is the cancer affected by the treatment? If a certain percentage of patients respond favorably, the treatment is then considered effective enough to go on to Phase III.

Phase III: Is it Better Than the Current Standard Treatments?
Phase III compares the effectiveness of the new treatment against the standard treatment for a particular cancer. Even if a treatment was found to be effective in Phase II, it is important for doctors to understand how well a particular treatment performs relative to current available treatment options. This phase determines whether a new treatment is more effective (or possibly less toxic) than the current standard of care. Phase II trials usually include a small number of people whereas Phase III trials usually enroll hundreds to thousands of participants in order to gather large amounts of data from patients of various ages, multiple ethnicities and both genders so that the results can be applied to a larger population.

Once a drug has been proven successful in a Phase III trial, the researchers can submit an application for FDA approval. If the data from clinical trials meet the FDA standards, the treatment will be approved for a specific use.

(Adapted from People Living With Cancer, an ASCO website. For more complete information go to www.cancer.net and link to clinical trials)

Finding an Appropriate Clinical Trial
Certain websites can be very efficient in finding a clinical trial. However, your doctor is the best resource for finding a clinical trial that’s right for you. If you wish to search the web for clinical trials, there are several websites that might prove beneficial to you. To find trials sponsored by drug companies go to www.centerwatch.com. To find government-sponsored trials go to www.cancertrialshelp.org. Both sites let you search the cancer type and the location of the participating hospital nearest you. The NCI’s website (www.cancer.gov) also includes a comprehensive list of trials but in technical terminology.

Who Pays for the Costs Associated with a Clinical Trial?
Health insurance and managed care providers often do not cover the patient care costs associated with a clinical trial. What is covered varies among insurance companies and for each trial. Oftentimes, the study drug itself will be free of charge but the patient is responsible for the doctor’s visits as well as the follow-up tests that monitor his/her condition throughout the trial process. It may be helpful to have someone from the research team talk about coverage with a representative from your insurance company.

Understanding the Risks and Rewards
As you consider your treatment options, keep in mind some of the benefits of clinical trial participation: In general, doctors and nurses who are involved in clinical trial research are aware of the latest cancer treatment advances. Therefore, your participation can afford you access to cancer treatments that are not yet widely available. Should those treatments be particularly successful, you would be among the first to benefit. Second, those involved in clinical trials receive very close healthcare monitoring to detect and track both treatment progress and potential side effects. Third, many who participate in clinical trials derive great satisfaction from contributing to the advancement of cancer research that may benefit future cancer patients. Finally, participants in clinical trials increase their sense of empowerment as they take a more active role in their own treatment process.

Along with the rewards there are also risks to consider. With each clinical trial, especially Phase I trials, there are potential side effects and because the treatment is new sometimes these side effects are unknown and unpredictable. There is the possibility that the new treatment or intervention is not as effective as the current treatment. Also, since everyone reacts to treatments differently, it may be that while the new intervention is more effective for others, it may not be as effective for you.

Clinical trials tend to take place in larger, urban hospitals. For most, this reguires more frequent trips to the clinic for closer healthcare monitoring. These trips may be challenging since, transportation to the larger hospital centers may be difficult to arrange plus some may find it difficult to obtain transportation coverage from their health insurer.

Ultimately, the decision to participate in a clinical trial is highly personal. It involves careful consultation with your medical team to understand the potential risks and rewards of any particular clinical trial with respect to your situation.

(Adapted from Coping Magazine, March 2006)

For Clinical Trial Information

National Cancer Institute
www.cancer.gov ............................................................................. 1-800-4-CANCER
Coalition of National Cancer Cooperative Groups
www.cancertrialshelp.org .............................................................. 1-877-520-4457
American Cancer Society: Clinical Trials Matching Service
www.cancer.org .............................................................................. 1-800-ACS-2345

TIP #8 Making Your Decision about Clinical Trials
Before you decide to take part in a clinical trial, you should know as much as possible about it. Be sure to consult with your medical team about the risks and benefits involved in your participation. Ask your medical doctor for more details on the trial such as:
· What is the purpose of the study?
· How many people will be included in the trial?
· What does the study involve? What kinds of tests and treatments will I have?
· How are treatments given and what side effects should I expect?
· What are the risks and benefits of each protocol?
· How long will the study last? What type of long-term follow-up care is provided?
· Will I have any costs? Will any of the treatments be free? What does my insurance cover? Is financial aid available?
SOURCE: American Cancer Society

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