Clinical trials are research studies that involved people. These studies test new ways to prevent, detect, diagnose or treat diseases.
Yes. Cancer clinical trials differ according to their primary purpose:
For more information, visit http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials
Clinical trials give eligible participants the opportunity to:
To help you decide if you want to be in a study, U.S. Food and Drug Administration requires that you be given information about the study before you agree to take part. This is known as informed consent.
The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts, risks and potential benefits.The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Many of these answers also will be contained in the informed consent document patients receive if they are eligible and considering participation in a clinical trial.
Every clinical trial has a protocol, or action plan, that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. Each study includes guidelines for who can and cannot participate. These guidelines are called eligibility criteria.
Eligibility criteria may include age, sex, medical history, and current health status. Eligibility criteria for cancer treatment trials often include the type and stage of cancer, as well as the type(s) of cancer treatment already received. Your doctor will make sure you are eligible for the study before you begin.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.
An IRB can stop a clinical trial if the researchers are not following the protocol or if the trial appears to be causing unexpected harm to the study participants.
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A placebo is an inactive pill, liquid or powder that has no treatment value.
The use of placebos as comparison or “control” treatments in cancer treatment trials is rare. If a placebo is used by itself, it is because no standard treatment exists.
In such a case, a trial would compare the effects of a new treatment with the effects of a placebo. More often, however, placebos are given along with a standard treatment. For example, a trial might compare the effects of a standard treatment plus a new treatment with the effects of the same standard treatment plus a placebo.
Be sure you understand what kind of study you would be entering and what it might mean for your treatment.
Before joining a clinical trial, it is important to know how the costs of your care will be covered. Some clinical trials cover patient health care costs directly related to the research. Other costs of care may be covered by private or public insurance companies. To learn all the facts, be sure to discuss potential costs with your health care provider. Information regarding patient health care costes will also be reviewd with you in the Patient Informed Consent, prior to your participation in a clinical trial.
For additional information on clinical trial health care costs, visit the links below:
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Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
You will receive information about a trial in which you’re interested; a personalized assessment, and answers to your questions. The staff will work with you and your personal physician to determine whether you meet eligibility criteria. If you meet the criteria and are still interested in participating in a clinical trial, you will be asked to review and sign a patient consent form detailing what will occur during the study, what your rights are as a participant and all known side effects of any medication.Once you enroll in a clinical trial, our staff will carefully monitor your progress.
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