Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Studies try to answer scientific questions and 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 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 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.

Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision, you should:

Learn as much as possible about your disease and the trials that are available to you. See other sections of our Web site for general cancer information, as well as for guidance on how to find current clinical trials that might be appropriate for you.

Then, talk about this information and how you feel about it with your doctor and/or nurse, family members and friends to help you determine what is right for you.



WHAT ARE THE POTENTIAL RISKS AND BENEFITS OF CLINICAL TRIALS?

Potential benefits include:

  • Health care provided by leading physicians in the field of cancer research.
  • Access to new drugs and interventions before they are widely available.
  • Close monitoring of your health care and any side effects.
  • A more active role in your own health care.
  • If the approach being studied is found to be helpful, you may be among the first to benefit.
  • An opportunity to make a valuable contribution to cancer research.

Potential risks include:

  • New drugs and procedures may have side effects or risks unknown to the doctors.
  • New drugs and procedures may be ineffective, or less effective, than current approaches.
  • Even if a new approach has benefits, it may not work for you.


HOW ARE PARTICIPANTS PROTECTED?

The government has a system designed to protect human research subjects. Before a government-funded clinical trial can begin, the trial plan (also called a protocol) must be approved. During the trial, review committees make sure that the plan is being followed and participants are being protected.

There is also a related Web-based CME/CEU course called Human Participant Protections:

Education for the Research Team.
Regulations require the researchers performing studies to thoroughly inform patients about a study's treatments and tests and their possible benefits and risks before a patient decides whether or not to participate in any study. This process is called informed consent.



WHAT IS INFORMED CONSENT?

Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate . In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about:

  • the study approach
  • the intervention given in the trial
  • the possible risks and benefits
  • the tests you may have

Don't hesitate to ask questions until you have all the information you need. While informed consent begins before you agree to participate in a trial, you should feel free to ask the health-care team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want -- before the study starts or at any time during the study or follow-up period.



COULD I RECEIVE A PLACEBO?

In treatment trials involving people who have cancer, placebos ("dummy" pills that contain no active ingredient) are very rarely used. Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known for a cancer based on results of past research. In these studies, patients are randomly assigned to one group or another. When no standard treatment exists for a cancer, a study may compare a new treatment with a placebo. However, you will be told about this possibility during informed consent, before you decide whether or not to take part in the study.



WHAT HAPPENS DURING A TRIAL?

If you decide to participate in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians, and other health care professionals. They will provide your care, monitor your health carefully, and give you specific instructions about the study.
Participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Team members also may continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.

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

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

POSSIBLE RISKS AND BENEFITS

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

PARTICIPATION AND CARE

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

PERSONAL ISSUES

How could being in this study affect my daily life?
Can I talk to other people in the study?
Cost Issues?
Will I have to pay for any part of the trial such as tests or the study drug?
If so, what will the charges likely be?
What is my health insurance likely to cover?
Who can help answer any questions from my insurance company or health plan?
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:

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

Visit the following pages for cancer centers offering clinical trials:

States A-M States N-Z

To obtain clinical trial listings for a specific type of cancer Click Here and you will be taken to "ClinicalTrials.gov". There you can search for a particular type of cancer and it will list trials that are currently being conducted regarding it.




| Cancer Centers Offering Clinical Trials (States A | Cancer Centers Offering Clinical Trials (States N- |

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