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What is a clinical trial?

 

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 do clinical trials exist?

 

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

 

Are all clinical trials the same?

 

No, there are 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 different 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

Goals:

 

Test a new treatment in humans that has been tested in the laboratory and in animal studies.

Learn how the human body responds to a new treatment and what the side effects are.

Find the best way to give a new treatment.

Find the highest dose of a new treatment with acceptable side effects.

 

Method:

 

Patients are given a low dose of the treatment and are observed for side effects.

The doses are increased according to a set plan in groups of patients until side effects become potentially dangerous.

 

Patients:

 

Trial is offered only to patients whose disease has not improved with other less experimental treatments.

Usually relatively few patients are enrolled in any one of the trials.

 

Potential Benefits:

 

A few patients may respond to the new treatment and show improvement of their disease (usually less than 1 in 20).

Future patients benefit from what is learned in this type of trial.

 

Potential Risks:

 

Side effects of the new treatment may be worse than expected.

Patients may spend more time in the hospital or clinic to receive the new treatment or have tests done to evaluate the response.

Most patients do not directly benefit from these studies.

 

Phase II

 

Goal:

 

Learn if a new treatment works in patients with specific types of cancer.

Learn more about how a new treatment affects the human body.

 

Method:

 

Patients with different types of cancer receive a new treatment using the highest but still safe dose found in a Phase I trial.

Patients are observed for improvements in their cancer and any side effects.

 

Patients:

 

Trial is offered to patients who have not improved with other available treatments.

 

Potential Benefits:

 

A few patients may respond well to the new treatment and show definite improvement of their disease.

Future patients will benefit if the treatment works better than current treatments.

 

Potential Risks:

 

Benefits of the treatment are not known.

Patients may spend more time in hospital or clinic to receive the new treatment and to have tests done to study their response to the treatment.

Many Individual patients do not directly benefit from these studies.

 

Phase III

 

Goal:

 

Learn if a new treatment that has been shown effective in treating a specific type of cancer in a Phase II trial is better in some way (more cures, longer control of disease, fewer or less serious side effects, or fewer days in the hospital) than the best current treatment for the disease.

These trials are usually offered to patients who have just been diagnosed with cancer.

 

Method:

 

Patients are assigned by a method called randomization to one of two or more treatment plans, one of which is the standard treatment.

 

Patients:

 

Patients with the same type of cancer who otherwise would receive best current treatment.

 

Potential Benefits:

 

Trial offers the most up-to-date treatments with the best-known results for improvement or cure of their disease.

Some patients may respond better to the new treatment or show the same anti-cancer effects but with fewer side effects.

Future patients will benefit if the treatment works better than current treatments.

 

Potential Risks:

 

The new treatment being compared is considered to be at least as good as the standard treatment, but it is not known for certain whether the new treatment will be better than the standard treatment either in curing more patients or in producing fewer side effects.

 

Patients may spend more time in hospital or clinic to have tests done to study and compare their responses to the treatment.

 

Sometimes new side effects are revealed with the new treatment, which means the new treatment might have to be modified

For more information, please see the National cancer Institute's brochure, Taking Part in Clinical Trials: Cancer Prevention Studies.

Benefits and Risks of Clinical Trials

 

You may be asking "How do I benefit from taking part in a clinical trial"? In a clinical trial you receive the most up-to-date treatment. Just as you benefit from what has been learned from past clinical trials, others with cancer in the future will be helped by what is learned from clinical trials today.

 

The new treatments may have different or more serious side effects than those known with the best current treatment.

 

You may spend more time at the clinic or hospital getting treatment or tests.

 

The new treatment may not work for your disease. Do I have to be on a clinical trial?

 

You may choose not to enter a clinical trial. You may also choose to withdraw from a trial at any time. Your choice will not affect how the health care team feels about you. You will continue to receive the best possible care.

 

Key Point: If you decide not to enroll in a clinical trial, you will receive the standard treatment. Standard treatment is the best-known treatment at the time, for your particular circumstances but it is important to seek a multidisciplinary approach to care at all times.

 

 

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