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Clinical Trials Patient Information

Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide information about clinical trials.  

What is a clinical trial?

Clinical trials are research studies that test how well new medical approaches work for patients. Each study answers scientific questions and tries to find a better way to prevent, screen for, diagnose or treat a disease.  People who take part in cancer clinical trials have the opportunity to contribute to knowledge about the cancer, as well as progress in the treatment and prevention of cancer. People also receive up-to-date care from doctors who are cancer experts.  The terms trial, protocol and study are used interchangably.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, help others by contributing to cancer research and possibly help find better treatments. Patients who participate in clinical trials are the first to receive the newest cancer treatments, as well as the best quality of care.

Who can participate in a clinical trial?

All clinical trials have strict guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and factors that disallow someone from participating are called "exclusion criteria." These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.Before joining a clinical trial, a participant must qualify for the study.

Treatment trials seek patients with specific cancers to participate in the clinical trial, while prevention trials need healthy participants or people at a high risk for developing cancer. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that investigators will be able to answer the questions the detailed clinical trial study. Ask your doctor if you are eligible for any clinical trials.

If you are eligible for a clinical trial, a doctor involved with the clinical trial or another member of the clinical trials team will carefully explain the details of the clinical trial to you and answer any questions you may have. You will also be given a written copy of information about the trial, called a consent form.  It is often helpful to talk to family members or friends about deciding to join a trial.

No one is ever required to participate in a clinical trial. Participation in a clinical trial is completely voluntary, and a trial participant may always decide to stop participating in a clinical trial without it affecting their relationship with their doctor, other medical staff or their medical care.

Are there alternatives to the clinical trial?

Usually standard treatments exist that people can receive rather than participating in a clinical trial. Sometimes you can even receive the same trial therapy without enrolling in the clinical trial. Other times the only way to receive a certain drug or treatment is to participate in the clinical trial.

What are the different types of clinical trials?

Treatment trials test new treatments (like a new cancer drug or new combinations of drugs; new surgery techniques or radiation therapy; or new treatment methods such as gene therapy) for cancer patients.

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, to prevent cancer from returning or to prevent a new cancer from occurring in people who already have had cancer. New methods of testing for cancer may be studied to determine better ways of detecting cancer at the earliest stages when it is most treatable.

Cancer control trials test new treatments, such as medicines, supplements or other techniques to treat or prevent cancer symptoms and the side effects of cancer treatments.

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 a drug’s effectiveness and protects the patients. Clinical trials are usually classified into one of three phases:

Phase I trials: These first studies 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 or radiation therapy procedure in comparison to the current standard treatment. 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.