Introduction to Clinical Trials for Parkinson's Disease
You may have heard about clinical trials from your doctor, read or heard advertisements in the newspaper or on the radio, or found out about trials in your area through a support group or association. Before you decide to participate in a trial, you should be aware of the potential benefits and risks. This guide provides a brief overview of the clinical trial process.
What Is a Clinical Trial?
A clinical trial is a research program conducted in patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating diseases and special conditions.
During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are hoped to be at least as effective as -- or possibly more effective than -- the standard.
New treatment options are first researched in the laboratory, where they are carefully studied in the test tube and in animals. Only the treatments most likely to work are further evaluated in a small group of humans prior to applying them in a larger clinical trial.
When a new medical treatment is studied for the first time in humans, scientists don't know exactly how it will work. With any new treatment, there are possible risks as well as benefits. Clinical trials help doctors discover the answers to these questions:
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How Does the Clinical Trial Process Work?
Clinical trials are conducted in phases -- each designed to find out specific information. Each new phase of a clinical trial builds on information from previous phases.
Participants may be eligible for clinical trials in different phases, depending on the participants' overall condition. Most clinical trial participants take part in phases III and IV.
In a phase I clinical trial, a new research treatment is given to a small number of participants. The researchers determine the best way to give the new treatment and how much of it can be given safely.
Phase II clinical trials determine the effectiveness of the research treatment on the disease or condition being evaluated.
Phase III clinical trials compare the new treatment with the standard treatment.
Phase IV clinical trials apply the new treatment to patient care. For example, a new drug that was found effective in a clinical trial may then be used together with other effective drugs to treat the particular disease or special condition in a select group of patients.
What Are the Advantages of Participating in a Clinical Trial?
The advantages of participating in a clinical trial include the following:
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Source article on WebMD
What Are the Disadvantages of Participating in a Clinical Trial?
Because the drug or device being studied is new, all of the risks and side effects of the treatment are not known at the beginning of the clinical trial. There may be unknown side effects (as well as hoped-for benefits). Patients will be informed of any known side effects they could experience, as well as any side effects that occur or become known while they are participating in the trial.
It is also important that you realize that if you participate in a clinical trial you may be given a placebo, which is a sugar pill containing no medicine. These tablets are used to determine if the real treatment is really working effectively. Trials are conducted in such a way that you will not be told if you're getting the real treatment or a "fake" treatment.
How Would My Care Be Different if I Participated in a Clinical Trial?
What Is Informed Consent?
Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.
You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the researchers to explain parts of the form or the trial that are not clear. (See "Important Questions to Ask" below.)
You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
© 2005-2015 WebMD, LLC. All rights reserved.
Source article on WebMD
How Does the Clinical Trial Process Work?
Clinical trials are conducted in phases -- each designed to find out specific information. Each new phase of a clinical trial builds on information from previous phases.
Participants may be eligible for clinical trials in different phases, depending on the participants' overall condition. Most clinical trial participants take part in phases III and IV.
In a phase I clinical trial, a new research treatment is given to a small number of participants. The researchers determine the best way to give the new treatment and how much of it can be given safely.
Phase II clinical trials determine the effectiveness of the research treatment on the disease or condition being evaluated.
Phase III clinical trials compare the new treatment with the standard treatment.
Phase IV clinical trials apply the new treatment to patient care. For example, a new drug that was found effective in a clinical trial may then be used together with other effective drugs to treat the particular disease or special condition in a select group of patients.
What Are the Advantages of Participating in a Clinical Trial?
The advantages of participating in a clinical trial include the following:
© 2005-2015 WebMD, LLC. All rights reserved.
Source article on WebMD
What Are the Disadvantages of Participating in a Clinical Trial?
Because the drug or device being studied is new, all of the risks and side effects of the treatment are not known at the beginning of the clinical trial. There may be unknown side effects (as well as hoped-for benefits). Patients will be informed of any known side effects they could experience, as well as any side effects that occur or become known while they are participating in the trial.
It is also important that you realize that if you participate in a clinical trial you may be given a placebo, which is a sugar pill containing no medicine. These tablets are used to determine if the real treatment is really working effectively. Trials are conducted in such a way that you will not be told if you're getting the real treatment or a "fake" treatment.
How Would My Care Be Different if I Participated in a Clinical Trial?
What Is Informed Consent?
Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.
You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the researchers to explain parts of the form or the trial that are not clear. (See "Important Questions to Ask" below.)
You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
© 2005-2015 WebMD, LLC. All rights reserved.
Source article on WebMD
Source: http://www.rxlist.com
Participants may be eligible for clinical trials in different phases, depending on the participants' overall condition. Most clinical trial participants take part in phases III and IV.
In a phase I clinical trial, a new research treatment is given to a small number of participants. The researchers determine the best way to give the new treatment and how much of it can be given safely.
Phase II clinical trials determine the effectiveness of the research treatment on the disease or condition being evaluated.
Phase III clinical trials compare the new treatment with the standard treatment.
Phase IV clinical trials apply the new treatment to patient care. For example, a new drug that was found effective in a clinical trial may then be used together with other effective drugs to treat the particular disease or special condition in a select group of patients.
Source: http://www.rxlist.com
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