CLINICAL TRIALS

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Why are there clinical trials?

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

What are the different types of clinical trials?

Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer.

Screening trials test the best way to find cancer, especially in its early stages.

Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:

Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

Anyone considering a clinical trial should feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give some you ideas as you think about your own questions.

The Study

1. What is the purpose of the study?
2. Why do researchers think the approach may be effective?
3. Who will sponsor the study?
4. Who has reviewed and approved the study?
5. How are study results and safety of participants being checked?
6. How long will the study last?
7. What are my responsibilities if I participate?

Possible Risks and Benefits

1. What are my possible short-term benefits?
2. What are my possible long-term benefits?
3. What are my short-term risks, such as side effects?
4. What are my possible long-term risks?
5. What other options do people with my risk of cancer or type of cancer have?
6. How do the possible risks and benefits of this trial compare with those options?

Participation and Care

1. What kinds of therapies, procedures and /or tests will I have during the trial?
2. Will they hurt, and if so, for how long?
3. How do the tests in the study compare with those I would have outside of the trial?
4. Will I be able to take my regular medications while in the clinical trial?
5. Where will I have my medical care?
6. Who will be in charge of my care?

Personal Issues

1. How could being in this study affect my daily life?
2. Can I talk to other people in the study?

Cost Issues

1. Will I have to pay for any part of the trial such as tests or the study drug?
2. If so, what will the charges likely be?
3. What is my health insurance likely to cover?
4. Who can help answer any questions from my insurance company or health plan?
5. Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for Asking your Doctor About Trials

When you talk with your doctor or members of the research team:

1. Consider taking a family member or friend along, for support and for help in asking questions or recording answers.
2. Plan ahead what to ask--but don't hesitate to ask any new questions you think of while you're there.
3. Write down your questions in advance, to make sure you remember to ask them all.
4. Write down the answers, so that you can review them whenever you want.
5. Consider bringing a tape recorder to make a taped record of what's said (even if you write down answers).

For more information on clinical trials visit: http://cms.komen.org/komen/AboutBreastCancer/Treatment/s_002756?ssSourceNodeId=298&ssSourceSiteId=Komen. To review open studies at the Karmanos Cancer Center and their qualifications, please see: www.karmanos.org/ctoweb

Rev. 10-31-06