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Research

Frequently Asked Questions About Research and Clinical Trials

What are clinical trials?

Clinical trials are studies which evaluate new cancer treatments and ways to detect cancer. Clinical trials find better ways to treat cancer and help cancer patients, and play a key role in the progress against cancer.

The search for new cancer treatments or diagnostic tests often begins in the laboratory, where new drugs, agents, or procedures are tested on cells or animals. When laboratory and animal testing show that the new drugs and treatments destroy cancer cells and are safe, a clinical trial is designed to see if the new drug or treatment destroys cancer cells in human beings. A clinical trial is one of the final stages of the long and careful research process.

Clinical trials may improve an existing or "standard" treatment for a specific cancer. The trials may test a new drug or agent or it may help to find new and better ways to care for people with cancer as they receive treatment.

Why take part in a clinical trial?

There are several reasons to participate. First, there is a chance that the drug or treatment being studied will be more effective than the standard treatment for the disease. Second, patients will receive close follow-up care from doctors and health care professionals who specialize in cancer. Third, patients may want to help scientists and health care professionals learn more about the treatment being studied so that others may benefit in the future.

In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, some patients, especially those with common cancers, often choose to receive their first treatment in a clinical trial.

How do clinical trials work?

Clinical trials are planned diagnostic or treatment programs. Oncologists (doctors who treat patients with cancer) and oncology (cancer) nurses follow a detailed, standardized plan (called a protocol) for each trial. The plan helps them answer questions about the treatment or diagnostic test being studied. It also helps them provide quality care for patients in the trial.

The planning for clinical trials is based on laboratory and animal research. Agents thought to be promising are tested for effectiveness against specific disease(s) and for unknown side effects.

Before a clinical trial starts, a scientific review board evaluates each proposed clinical trial to make sure it is scientifically sound and will be conducted in an appropriate manner. In addition, an institutional review board evaluates all proposals. This board is made up of health care professionals, administrators and individuals from the community. Clinical trials using drugs or agents not yet licensed by the U.S. Food and Drug Administration (FDA) must receive the approval of the FDA before patients can be treated with the new drug or agent. New cancer treatments go through three phases of testing before they can be approved for standard use.

When no standard treatment exists for a specific type of cancer, those receiving the new treatment may be compared to patients who do not receive treatment or who receive a placebo (a look-alike pill that has no active drugs.) The placebo is used to make sure that the drug is having an impact. You will be told if this is a possibility before you agree to take part in a study.

New treatments may be new drugs or agents that are used alone or combined with other treatments. Sometimes the new treatment is a new way of using a drug already known to be useful (for instance, a different dosage or schedule).

No matter which treatment is used, all patients taking part in a clinical trial are followed carefully by their doctor and nurse. Physical examinations, blood tests and x-ray examinations are done before, during and after each treatment. These examinations and tests are done to measure the effectiveness of the treatment and to help detect side effects.

Your role in a clinical trial may change or cease for one reason or another. Some clinical trials stop after a certain length of time. Your treatment may change if your disease becomes better or worse, or if side effects become severe. You also may stop participating in a clinical trial if at any time you or your doctor decide that the clinical trial is no longer the best treatment for you. If your treatment in the clinical trial is stopped, you then may be evaluated to see if another treatment, either a standard treatment or another clinical trial, could help you.

What are phases?

Clinical trials investigate different questions in different stages, and later phases build on earlier research. The phases of clinical trials are as follows:

In Phase I trials, researchers determine the safe dose of the new drug or agent and learn about its side effects. These trials usually include usually from 20 to 80 patients with a range of cancer types. Patients are usually divided into groups. Each group of patients is treated with different doses of the drug or agent so that the safest dose can be found. The highest dose of the drug that can be given safely to people (knowns as the maximum tolerated dose) is also determined.

Phase II clinical trials test the effectiveness of the new drug or agent in stopping or controlling the growth of tumor cells in a certain type of cancer. These studies typically involve 100-300 people.

The goal of Phase III clinical trials is to find which treatment – the new or the standard cancer treatment – is better. To gather information as quickly as possible, Phase III trials usually involve many patients (1,000-3,000) and often are performed at the same time in cancer research centers across the country. In many Phase III studies, patients are assigned randomly to receive either the new or the standard treatment. From what is known at the time, any one of the treatments chosen could be better or of equal help to the patient. Random assignment helps make certain study results are not biased.

Phase IV trials are performed when more information is needed about a drug which has been approved for use. These studies provide information about a drug's risks and benefits, as well as the best way to use it.

What about side effects?

Clinical trials have possible risks as well as benefits. Side effects are one risk. Side effects are problems that occur when treatment affects healthy cells. Common side effects of standard cancer treatments are fatigue, nausea, vomiting, decreased blood cell counts, hair loss and mouth sores. New treatments being tested may have these or other unknown side effects. Side effects vary from treatment to treatment and also vary from patient to patient. Many side effects may be prevented or decreased by medication and/or other measures to make you more comfortable.

Your doctor and nurse will review with you the possible risks and side effects from your treatment. They will watch for and help you manage any side effects that occur.

What steps need to be taken to participate in a clinical trial?

Every clinical trial is designed to answer a specific research question. Each study enrolls patients with specific types and stages of cancer and certain levels of health. Before you enter a trial, there is a process to make sure that you are eligible, and that you have all the information to decide if you want to participate.

First, your health care team will review your medical records. Your doctor will review your history and examine you. You may need to have more tests such as blood work, x-rays or scans. The team will review the information from your medical record and test results and decide if you meet all the criteria to enter the clinical trial. If you are found not to be eligible for a trial, this does not mean there are any problems with you. Trials are often written with strict criteria to keep all the people in the study similar, and certain people who fall outside the criteria are ineligible.

If you meet the criteria, your doctor and nurse then will discuss with you and your family the purpose of the clinical trial and what it involves. They will explain to you and your family the treatment plan, and other treatments available to you.

You will receive a consent form that must be signed before you enter or start on the clinical trial. Before you sign the consent form, you will be given time to completely review the form and to discuss the consent form with your family and friends. It is important that you write down any questions that you have so that you can discuss them with your doctor or nurse before you sign the consent form. After you have signed the consent form, you will be given a copy for your reference.

The consent form contains information about the treatment, known side effects and risks, possible benefits, potential costs and payments, and alternatives to the treatment. The consent form will indicate if you will need to be hospitalized for your treatment, and how long the treatment will take.

Participation in a clinical trial is voluntary. You may decide to stop treatment at any time during the clinical trial, and your doctor and nurse will support whatever choice you make. Choosing not to take part in or withdrawing from a clinical trial will not affect your ability to receive care at .

Making a decision to undergo treatment in a clinical trial takes time and careful consideration. It requires a commitment from you and your family or friends.

What if I'm worried or afraid?

It is not unusual to have some fears or concerns about being in a clinical trial. Many patients worry that they will become "just another research subject." Patients on clinical trials receive the same level of care from doctors and nurses that patients not participating in clinical trials receive. Patients on clinical trials are monitored and may undergo more frequent testing and exams to help evaluate their progress than those in standard care.

Whether or not they are participating in a clinical trial, patients regularly receive information about their condition and test results from their doctor and nurse. They learn about their disease, its treatment and ways to help themselves.

All patients with cancer and their families often have mixed emotions. They may feel anger, sadness, fear of the future or nervousness. Oncology nurses, doctors, psychologists and social workers understand this, and can give you and your family emotional support before, during and after the trial.

If you enter a clinical trial, you will be assigned to a nurse who is the clinical coordinator for the trial. This nurse monitors the scheduling and completion of tests, and makes sure and any side effects are recorded. He or she can discuss all aspects of the study with you before and during treatment. The clinical coordinator works closely with your doctor and nurses to plan your care.

Your clinical coordinator will provide you with a calendar so that you can remember when you are scheduled for treatments and tests. If you are giving yourself medications at home that are part of the clinical trial, you may be given a diary card on which to record these medications.

Who will get to see my confidential medical records?

Information that is learned about an individual participating on a clinical trial is confidential. Study sponsors and monitors may review your medical records to ensure that clinical trial guidelines are being followed. Even then, any information that is reported about your case will not identify you by name. Generally, only the results of the whole group of patients on the clinical trial are reported to the public. Data may be shared with health care professionals so that the findings can be used to help treat other people with cancer, but no one in the trial is identified by name.

How much does it cost to join a clinical trial?

The care provided before, during and after a clinical trial usually is billed to the patient's health insurance. Laboratory and x-ray studies performed as part of routine care are billed in the same manner as are all other hospital or care-related charges. You will have to pay for services that are not covered by your insurance plan. However, any tests that are done only to fulfill the research requirements of the clinical trial are usually done without charge to you. New drugs or agents that are being tested as part of the clinical trial also may be free of charge to you during your participation in the clinical trial.

Before you start a clinical trial, financial counselors can help you and your family understand the costs for which you will be responsible. They can help determine which costs you will need to pay and which cost are covered by your insurance. They also can discuss methods of payment with you. If you have other concerns about your finances or your present employment, you may request a meeting with a clinical social worker. The social worker will be able to advise you on your situation, and inform you of any additional resources that may be of use to you.

Where is treatment given?

Patients enrolled in clinical trials may receive their treatment in:

Care is provided by oncologists and oncology nurses. Parts of some clinical trials also may be carried out by the doctor who referred you to the trial.

What should I bring up with my doctor if I want to be in a clinical trial?

Your health care team wants to make certain that you have all the information you need before and during your participation in a clinical trial.

Please share your questions or concerns with your doctor and nurse. You may wish to print out and take this list of questions along with you to your next appointment.