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Learn About Clinical Trials

Only you can make the decision about participating in a clinical trial

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Clinical trials carry potential benefits and risks. Take time to carefully weigh these factors in deciding whether this option is right for you.

Potential Benefits

this option is right for you.

Potential Risks

Types of Trials

Treatment Trials
This is usually the first type of clinical trial that comes to mind when they're mentioned. These trials test new treatments, such as a new drug, approach to surgery or radiation therapy, new combinations of treatments, or new methods, such as gene therapy.

Prevention Trials
In general, prevention trials study the effects of doing a particular thing - such as quitting smoking - or taking a particular medicine or nutritional supplement to find out whether it helps prevent cancer.

Other
Other trials study ways to reduce the risk of getting cancer, find better ways to detect cancer and improve quality of life for cancer patients and survivors.

Clinical Trial Phases

Clinical trials, particularly trials assessing new treatments and prevention methods, progress in an orderly series of steps, called phases. These phases help to protect patients and ensure that researchers ask and answer questions in a way that will result in reliable information about the drug or new treatment option. Clinical trials are usually classified into three phases:

• Phase 1 trials:
  These first studies in people evaluate how a new drug should be given (for example, by mouth or injection), how often and what dose is safe. Because less is known about the possible risks and benefits of in phase 1, these studies only involve a limited number of patients who would not be helped by other known treatments.
• Phase 2 trials:
  A phase 2 trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase 2 studies usually focus on a particular type of cancer and involve a small number of people because of the risks and unknowns involved.
• Phase 3 trials:
  These studies test a new drug, new combination of drugs or a new surgical procedure in comparison to the current standard. A participant usually is assigned to the standard group or the new treatment group at random. Randomization, the practice of assigning patients randomly to a treatment method, is important to ensure that the process is free of all biases or human factors that otherwise may skew results. It also ensures that all patients have equal chances of receiving the new or standard treatments. Phase III trials often enroll many people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.

In some drug studies, researchers may wish to compare the effectiveness of a potential new treatment against a placebo, or a dummy pill that contains no active ingredients. This rarely occurs in cancer research. Instead, the effectiveness of new approaches may be compared with that of the current, standard approach to care. In some cases, however, if no standard treatment exists for a cancer, a clinical trial may use a placebo. If this is the case, you will be notified that you could receive a placebo, rather than active treatment, before you enroll as a participant.

Informed Consent

Before you agree to participate in any clinical trial, you will be educated about the study. You will receive information about the key aspects of the study, such as what types of treatment you may receive during the clinical trial. This is the beginning of a formal process called informed consent. In addition to discussing the study with your doctors or nurses, a written consent form will be available for you to take home to read and discuss with your family and friends. The consent form will include:

• the study approach;
• the intervention, for example a new drug or treatment, given in the trial;
• the possible risks and benefits; and
• the tests you may have.

If you decide to participate in the study, you will sign the consent form, but this is not the end of the informed consent process. Informed consent is designed to facilitate an ongoing conversation with your patient-care team so that you can make educated decisions about whether to participate - or to continue participating - in a clinical trial. Never hesitate to ask questions at any time about any aspect of the study or your care. You always can change your mind and leave the study whenever you want, without forfeiting access to other treatment.

The research team you work with has a duty to keep you informed, help you understand the information and answer your questions. They understand that people like you are making their research possible through your willingness to participate.

Further Patient Protection

Informed consent is just one of many safeguards in place to ensure that patients who participate in clinical trials are protected. The federal government regulates most clinical research. All researchers prepare plans of action for their studies, which is called a protocol. It outlines how many people will take part in the study, what medical tests they will receive and how often, as well as the treatment plan. The same protocol is used by every doctor who takes part in the study.

Before a study can proceed, its protocol must be reviewed and approved by the University of Michigan's Institutional Review Board, which is composed of doctors, ethicists and members of the community. They ensure that the trial is safe and doesn't pose unethical risks to patients.

Eligibility

Each study has its own guidelines for who can participate, called eligibility criteria. To ensure reliable results, researchers want to study patients who are alike in key ways. Examples of criteria for participating in a study might require you to have a particular type and stage of cancer or be a certain gender or age.

These guidelines help to protect patients by ensuring that people who would likely be harmed by study drugs or other treatments are not enrolled. After the trial is completed, it helps doctors know which patient groups will benefit from the new treatment, if it is proven to work. For example, a treatment might work well for people with one kind of cancer, but not for those with a different cancer.

What's It Like?

Clinical trials take place in the same setting where standard patient care occurs. Doctors, nurses, social workers and other health-care professionals will be part of the team that cares for you, just as it is for all patients at the U-M Comprehensive Cancer Center.

As a clinical trial participant, you may have more tests and office visits that you otherwise would. You will follow the treatment regimen prescribed by your physician and may have other responsibilities, such as keeping a log or filling out forms about your health. Some studies continue to follow up with patients after the treatment is over.

Financial Concerns

The study's sponsor usually pays for the cost of the specific drugs or intervention being evaluated. It also usually pays for costs associated with any special testing or extra office visits required.

"Routine patient care costs" are the usual costs of medical care, which you would receive regardless of whether you were participating in a clinical trial. This may include expenses such as doctor visits, hospital stays, clinical laboratory tests and X-rays. Some health plans will not cover these costs once you join a trial, even though studies show that they are not appreciably higher than costs for patients who do not participate. Ask the staff at your health plan whether your insurance will cover these routine costs if you enroll in a clinical trial.

In Michigan, private insurance plans, health-management organizations and the Michigan Medicaid Program are required to pay for Phase 2 and 3 cancer clinical trials that are sponsored by the National Institutes of Health, the National Cancer Institute, FDA, U.S. Department of Defense, U.S. Department of Veterans Affairs, Centers for Medicare and Medicaid Services, or Centers for Disease Control and Prevention. If your health plan still does not cover the trial you are considering, resources are available to help you find financial assistance. Let your health-care team know so they can put you in touch with someone who can help you sort matters out.

How Trials Are Used

After Phase 1 or 2 clinical trials are completed, researchers examine the data they've collected from patients like you and decide whether to move onto the next phase with the treatment or stop testing the drug because it is not safe or effective. When a Phase 3 study is completed, researchers decide whether the results have medical importance. After this analysis is complete, researchers will inform the medical community and the public by publishing the results of trials in scientific or medical journals.

Most journals have a peer review process, in which experts critique an article before it is published to make sure the analysis and conclusions are sound. Important findings may be featured in the news media. If an intervention is proven safe and effective, it may become the new standard of care. Clinical trials are tools for building on what we already know to progressively improve the quality of cancer care and prevention available to everyone.

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See also:
From Patient to Participant

UMCCC Clinical Trials on the Engage website

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This site is part of the U-M Health System. The information presented is not a tool for self diagnosis or a substitute for professional care. © 2008 U-M Comprehensive Cancer Center