Criteria for Participation in Clinical Trials

Each clinical research study has criteria that patients must meet before they can participate. Common criteria includes:

• Age and gender

• Type of cancer

• Stage (extent) of cancer

• Previous treatments that you must, or must not have had

• Results of certain laboratory tests

• Medicines that you are currently taking

• Other medical conditions – the study treatment could have an impact on other health problems

• Previous history of any other cancer

Deciding to Participate in a Clinical Trial

When you need treatment for your cancer, clinical research studies may be an excellent option for you. Deciding to join a study is an important and personal decision. It is something only you, with the help of those close to you and your doctors and nurses, can decide.

As a treatment option, a clinical research study has possible benefits as well as potential risks. You may want to discuss the following issues with your doctor and the people who are close to you.

Possible Benefits

• You may have more treatment options.

• If and/or when a new treatment is proven to work, you may be among the first to benefit.

• By looking at the pros and cons of a clinical research study and your other treatment choices, you are taking an active role in a decision that affects your life and health.

• In some studies, you may receive additional medical tests or the treatment being studied at less cost or no cost to you.

• You have the opportunity to help others by contributing to research that can improve cancer treatment.

• You may have potentially improved health status should the study treatment prove effective.

• A more comprehensive cancer care team including the assistance of trained research nurses and associates.

Potential Risks

• New treatments under study may not prove to be more beneficial than standard care.

• New treatments may have unexpected side effects, or side effects that are worse than those of standard treatment.

• Even if a new treatment has benefits, it may not work well for you. Even standard treatments, while proven to be effective for many people, do not help everyone.

• Health insurance and managed care providers do not always cover all patient care costs for a study. What they do cover varies by plan and by study. To find out in advance what costs are likely to be paid, check with your insurance provider and talk to a doctor, nurse or social worker who is part of the study team.