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Clinical Trials Q & A
What Is A Clinical Trial?
A clinical trial is a research study in which people help doctors find answers to scientific questions and find better ways to prevent, diagnose, and treat cancer. Studies are conducted in order to find out whether promising approaches are safe and effective.
Most clinical research involving the testing of a new drug progresses in a 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 also protects the patient.
Should I participate in a clinical trial?
The decision about whether or not to participate in a clinical trial is personal. Before you make this decision, however, it is important to learn as much as possible about your disease and the trials which may be available to you. You can then discuss the possibilities with your doctor and family members, and determine what is right for you.
What are the potential benefits of participating in a clinical trial?
Benefits of being a clinical trial participant include:
- Health care provided by leading physicians in the field of cancer research.
- Access to new drugs before they become generally available.
- A proactive role in your own health care.
- An opportunity to make a valuable contribution to cancer research.
What are the potential risks of participating in a clinical trial?
Risks associated with being a clinical trial participant include:
- New drugs may have side effects unknown to the doctors.
- New drugs may be ineffective, or less effective than a current standard of treatment.
- Even if some people in a clinical trial show response to a new drug, it may not be effective for you.
How are clinical trial participants protected?
Before a government-funded clinical trial can begin, the trial (protocol) plan must be approved. Regulations require the researchers conducting the trial to completely inform patients about the study's treatments and tests, and their possible benefits and risks. This process is called informed consent. You will be asked to sign an informed consent form if you decide to participate in the trial.
Is it possible I could receive a placebo if I choose to participate?
In treatment trials involving cancer patients, placebos are very rarely used. Many trials are designed to compare a new treatment with a standard treatment; that which is known to be the best treatment for a cancer based on results of past research. In these studies, patients are randomly assigned to one group or another.
Who is eligible to participate in clinical trials?
Each study has its own eligibility criteria. To find out whether you are eligible for a particular study, talk to your own doctor or the doctor responsible for enrolling patients in the study.
Where are the trials conducted?
Clinical trials may be conducted at one or two highly specialized cancer centers or it may be available at hundreds of locations at the same time. You would participate in the trial under the supervision of a team, including your physician, who would report your experience with the treatment to the center responsible for the overall coordination of the trial. Then, using information from all the participants, the trial is evaluated by scientific experts.
What is a "randomized" trial?
A randomized trial is one that assigns participants by chance to either the investigational arm or the control arm of all Phase III (and some Phase II) clinical trials. This is done using a computer program or a table of random numbers. The goal of this randomization is to produce comparable groups in terms of age, gender, and other key factors that effect the probable course of the disease. To further eliminate bias, randomized trials are sometimes "blinded". Single-blinded trials are those in which participants do not know which group they are in until the conclusion of the study. Double-blinded trials are those in which neither the participant nor the investigators know to which group the participant has been assigned until the conclusion of the study.
Who pays for patient care costs on a clinical trial?
Even if you have health insurance, your coverage may not include some or all of the costs associated with a clinical trial because these treatments are considered "experimental" or "investigational" procedures. It is always best to check with your insurance carrier, or contact the National Cancer Institute at 1-800-4-CANCER for other solutions.
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